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Found 11 results
510(k) Data Aggregation
K Number
K223310Device Name
Antimicrobial Silicone PHMB Foam Wound Dressing
Manufacturer
Advanced Medical Solutions Limited
Date Cleared
2023-04-05
(159 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Advanced Medical Solutions Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Antimicrobial Silicone PHMB Foam Wound Dressings are indicated for use in the management of
- · post-surgical incisions,
- · pressure sores,
- · venous stasis ulcers,
- · diabetic ulcers,
- · donor sites.
- · abrasions,
- · lacerations,
- · superficial and partial thickness burns,
- · dermatologic disorders,
- · other wounds inflicted by trauma and,
- · as a secondary dressing or cover dressing for packed wounds.
Device Description
Antimicrobial Silicone PHMB Foam Wound Dressing, is a polyurethane foam trilaminate dressing impregnated with Polyhexamethylene Biguanide (PHMB), an agent that protects the dressing from bacterial penetration and colonization. The foam in the dressing has a microporous hydrophilic foam structure that absorbs wound exudate and maintains a moist wound healing environment.
Based on in vitro performance data, the Antimicrobial Silicone PHMB Foam Wound Dressing provides a barrier to bacterial penetration through the dressing and the PHMB prevents colonization and proliferation of bacteria, yeast and mold within the dressing for up to 7 days. Antimicrobial Silicone PHMB Foam Wound Dressing, when tested in-vitro has demonstrated to be effective against gram positive bacteria, gram negative bacteria, yeast and mold challenge organisms within the dressing.
The perforated wound contact layer contains a gentle silicone adhesive that provides secure, nonirritating adhesion and supports non-traumatic removal during dressing changes.
The device is presented in a border (adhesive) version. The dressing is supplied sterile in a range of sizes between 10.24 in2 (64cm) to 64 in2 (400cm).
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K Number
K211878Device Name
LiquiBand XL
Manufacturer
Advanced Medical Solutions Limited
Date Cleared
2022-05-23
(336 days)
Product Code
OMD
Regulation Number
878.4011Why did this record match?
Applicant Name (Manufacturer) :
Advanced Medical Solutions Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LiquiBand® XL is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. LiquiBand® XL should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
Device Description
LiquiBand® XL is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes.
In vitro studies have shown that LiguiBand® XL acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
LiquiBand® XL also incorporates a self-adhering mesh that is approximated skin edges to provide temporary skin edge alignment to an incision until the liquid adhesive is applied to achieve skin closure.
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K Number
K183570Device Name
LiquiBand Plus
Manufacturer
Advanced Medical Solutions Limited
Date Cleared
2020-03-09
(444 days)
Product Code
MPN
Regulation Number
878.4010Why did this record match?
Applicant Name (Manufacturer) :
Advanced Medical Solutions Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LiquiBand® Plus is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand® Plus may be used in conjunction with, but not in place of, deep dermal stitches.
Device Description
LiquiBand® Plus topical skin adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-Octyl-cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single patient use applicator and packaged in a pouch. The LiquiBand® Plus topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand® Plus topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand® Plus topical skin adhesive polymerizes within minutes.
In vitro studies have shown that LiquiBand® Plus topical skin adhesive acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.
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K Number
K110458Device Name
SILVER ANTIMICROBIAL WOUND GEL
Manufacturer
ADVANCED MEDICAL SOLUTIONS LIMITED
Date Cleared
2011-03-14
(25 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial and full thickness wounds such as:
- Pressure ulcers
- Leg ulcers
- Diabetic ulcers
- Graft and donor sites
- Post-operative surgical wounds
- Trauma wounds (dermal lesions, trauma injuries or incisions)
- 1st and 2nd degree burns
- Abrasions and lacerations
Device Description
Silver Antimicrobial Wound Gel is an opaque, amorphous hydrogel containing a high (>80%) water content and hydrophilic polymer chains. This formulation increases the moisture within the wound through water donation which makes the gel effective in assisting the debridement and desloughing process in dry necrotic wounds, whilst maintaining a moist wound environment for optimal wound healing. Silver Antimicrobial Wound Gel contains an antimicrobial silver compound (silver carbonate) that is an effective barrier to bacterial penetration by inhibiting the growth of broad spectrum of microorganisms which come into contact with the gel. Silver Antimicrobial Wound Gel is available in various sizes, and is supplied in aluminium tubes fitted with screw caps. The tubes will be packed in a cardboard dispenser box, with a product insert.
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K Number
K091013Device Name
SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND
Manufacturer
ADVANCED MEDICAL SOLUTIONS LIMITED
Date Cleared
2009-07-30
(112 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silver PU Antibacterial Foam Dressings are indicated for the management of light to moderate exuding partial and full thickness wounds, such as: '. - Decubitus (pressure) ulcers - Diabetic ulcers 0 - Leg ulcers . - Graft and donor sites - Lacerations and abrasions 9 - 1st and 2nd degree burns - Trauma wounds (dermal lesions, trauma injuries or incisions) e - Post-operative surgical wounds The Silver PU Antibacterial Foam Dressings are indicated for external use only
Device Description
The Silver PU Antibacterial Foam Dressings is available in two variants: Silver PU Antimicrobial Foam Dressing - Non-Adherent variant consists of a low friction waterproof polyurethane film, which also provides a bacterial barrier, laminated to hydrophilic absorbent polyurethane foam with a silver coated nylon mesh wound contact layer. Silver PU Antimicrobial Foam Dressing - Island variant consists of a polyurethane waterproof membrane coated with pressure sensitive acrylic adhesive, which also provides a bacterial barrier, with a centrally located hydrophilic absorbent polyurethane foam with a silver coated nylon mesh wound contact layer. Each Silver PU Antibacterial Foam Dressing contains a minimum of 0.26mg/cm² of elemental silver, the antibacterial action of the silver protects the dressing from bacterial contamination and provides an effective barrier to bacterial penetration. The antibacterial properties of the dressing are effective for up to 7 days, as demonstrated in vitro, against a broad spectrum of microorganisms associated with wound infection, such as Staphylococcus aureus, including MRSA, Staphylococcus epidermidis, including MRSE, Strentococcus pvogenes, Enterococcus faecalis (VRE) and Escherichia coli. Silver Antibacterial Foam Dressings may reduce odour caused by micro-organisms in the wound. Odour reduction results from the antibacterial effect in the dressing. Silver PU Antibacterial Foam Dressings are soft, highly absorbent, conformable and create the ideal environment for moist wound healing. Silver PU Antibacterial Foam Dressings are suitable for use under compression bandaging. Silver PU Antibacterial Foam Dressings are available in various sizes and shapes. The dressings are packaged in individual pouches, then into shelf cartons.
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K Number
K090453Device Name
SILVER ALGINATE 11 WOUND DRESSING
Manufacturer
ADVANCED MEDICAL SOLUTIONS LIMITED
Date Cleared
2009-02-26
(3 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as:
- ·Post-operative wounds .
- Trauma wounds (dermal lesions, trauma injuries or incisions)
- Leg ulcers
- Pressure ulcers
- Diabetic ulcers
- Graft and donor sites
- Post-operative surgical wounds
- 1st and 2nd degree burns
- Partial and full thickness wounds
Silver Alginate II Dressing is indicated for external use only
Device Description
Silver Alginate II Dressing is a sterile, non woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (Silver Sodium Hydrogen Zirconium Phosphate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal.
The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to fourteen (14) days, based on in-vitro testing. Odour reduction results from the antibacterial effect in the dressing.
Silver Alginate II Dressing is an effective barrier to bacterial penetration.
Silver Alginate II Dressing protects the wound and aids autolytic debridement therefore facilitating wound healing.
The Silver Alginate II Dressing is available various sizes: 5cm x 5cm (2" x 2"), 10cm x 10cm (4" x 4"). 10cm x 12cm (4" x 4.75"). 15cm x 15cm (6" x 6"). 10cm x 20cm (4" x 8"), 20cm x 30cm (8" x 12") and 2.7cm x 30cm (1" x 12"). The dressings are packaged in foil pouches.
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K Number
K080503Device Name
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING
Manufacturer
ADVANCED MEDICAL SOLUTIONS LIMITED
Date Cleared
2008-11-12
(261 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silver Alginate IV Antimicrobial Wound Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as:
- . Post-operative wounds
- Trauma wounds (dermal lesions, trauma injuries or incisions) .
- Leg Ulcers ●
- Pressures Ulcers .
- Diabetic Ulcers .
- Graft and donor sites .
- Post-operative surgical wounds
- 1st and 2nd degree burns
- Partial and Full Thickness wounds
Silver Alginate IV Antimicrobial Wound Dressing is indicated for external use only
Device Description
Silver Alginate IV Antimicrobial Wound Dressing is a sterile, non woven pad or rope/ribbon/filler composed of a high M (mannuronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (silver carbonate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the dressing forms a gel, which aids autolytic debridement, whilst maintaining a moist environment for optimal wound healing and allows intact removal. The silver ions protect the dressing from a broad spectrum of microorganisms, such as a Staphylococcus aureus, including MRSA, Staphylococcus epidermidis, including MRSE, Streptococcus and bw, merceas faecalis (VRE), Pseudomonas aeruginosa, Escherichia Doli, and fungi such as Candida albicans , over a period of up to twenty-one (21) days, based on in-vitro testing, and may reduce odour caused by micro-organisms in the wound. Odour reduction results from the antibacterial effect in the dressing. Silver Alginate IV Antimicrobial Wound Dressing is an effective barrier to bacterial penetration. The dressing has pale golden appearance and is available in various sizes (5cm x 5cm, 10cm x 10cm, 10cm x 12cm, 15cm, 10cm x 20cm, 20cm x 20cm flat dressings; 2.7cm x 30cm room, 10cm x 12cm, 150m, 150mm x 2g rope dressings). The dressings are packaged in pouches.
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K Number
K081363Device Name
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING
Manufacturer
ADVANCED MEDICAL SOLUTIONS LIMITED
Date Cleared
2008-09-24
(132 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-Adherent Antimicrobial Alginate Dressing is an effective barrier to bacterial penetration. The barrier functions of the dressing may help reduce infection in moderate to heavily exuding partial and full-thickness wounds, including pressure ulcers, venous ulcers, diabetic ulcers, donor sites, traumatic and surgical wounds.
Non-Adherent Antimicrobial Wound Dressing is indicated for external use only.
Device Description
Non-Adherent Antimicrobial Alginate Dressing is a sterile, non woven pad composed of a high G (guluronic acid) alginate, carboxymethy)cellulose (CMC) and silver coated nylon fibres, laminated to a perforated, non-adherent ethylene methyl acrylate (EMA) wound contact layer. The dressing absorbs exudate and allows intact removal, whilst maintaining a moist wound environment. A moist wound environment is optimal for wound healing. The silver ions within the dressing protects the dressing from bacterial contamination. Odor reduction results from the antibacterial effect.
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K Number
K073197Device Name
SILVER ANTIMICROBIAL WOUND GEL
Manufacturer
ADVANCED MEDICAL SOLUTIONS LIMITED
Date Cleared
2008-08-28
(289 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silver Antimicrobial Wound Gel is indicated under the medical supervision of a healthcare professional for the management of dry to moderate exuding partial and full thickness wounds such as:
- . Pressure ulcers
- Leg ulcers .
- . Diabetic ulcers
- . Graft and donor sites
- . Post-operative surgical wounds
- . Trauma wounds (dermal lesions, trauma injuries or incisions)
- 1st and 2nd degree burns .
- Abrasions and lacerations .
Device Description
Silver Antimicrobial Wound Gel is an opaque, amorphous hydrogel containing a high (>80%) water content and hydrophilic polymer chains. This formulation increases the moisture within the wound through water donation which makes the gel effective in assisting the debridement and desloughing process in dry necrotic wounds, whilst maintaining a moist wound environment for optimal wound healing.
Silver Antimicrobial Wound Gel contains an antimicrobial silver compound (silver carbonate) that is an effective barrier to bacterial penetration by inhibiting the growth of broad spectrum of microorganisms which come into contact with the gel.
Silver Antimicrobial Wound Gel is available in various sizes, and is supplied in aluminium tubes fitted with screw caps. The tubes will be packed in a cardboard dispenser box, with a product insert.
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K Number
K070581Device Name
SILVER ALGINATE II WOUND DRESSING
Manufacturer
ADVANCED MEDICAL SOLUTIONS LIMITED
Date Cleared
2007-07-13
(134 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Silver Alginate II Dressing is indicated for the management of moderate to heavily exuding partial to full thickness wounds, such as:
- Post-operative wounds .
- Trauma wounds (dermal lesions, trauma injuries or incisions) .
- Leg Ulcers .
- Pressures Ulcers .
- Diabetic Ulcers ◆
- Graft and donor sites .
- Post-operative surgical wounds .
- 1st and 2nd degree burns .
- Partial and Full Thickness wounds .
Silver Alginate II Dressing is indicated for external use only
Device Description
Silver Alginate II Dressing is a sterile, non woven pad composed of a high G (guluronic acid) calcium alginate, carboxymethylcellulose (CMC) and ionic silver complex (Silver Sodium Hydrogen Zirconium Phosphate), which releases silver ions in the presence of wound fluid. As wound fluid is absorbed the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, and allows intact removal. The silver ions protect the dressing from a broad spectrum of microorganisms over a period of up to twenty-one (21) days, based on in-vitro testing. . Odour reduction results from the antibacterial effect in the dressing. Silver Alginate II Dressing is an effective barrier to bacterial penetration. Silver Alginate II Dressing protects the wound and aids autolytic debridement therefore facilitating wound healing. The dressing has an off-white appearance and is available in various sizes (5cm x 5cm, 10cm x 10cm, 15cm x 15cm, 10cm x 20cm, 20cm x 30cm flat dressings; 2.7cm x 30cm and 3cm x 44cm flat rope dressings; and 30cm x 2g rope dressings). The flat rope dressings are packaged in pouches and the flat rope and rope dressings are packaged in a blister pack.
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