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Found 21 results
510(k) Data Aggregation
K Number
K090254Device Name
SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)
Manufacturer
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C.
Date Cleared
2009-09-04
(214 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
**CONVATEC, A DIVISION OF E.R. SQUIBB **& SONS, L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Under the supervision of a healthcare professional, the Silver Hydrofiber® Wound Dressing Reinforced with Nylon may be used for the management of:
- Partial thickness (second degree) burns; .
- Diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of . mixed etiology) and pressure ulcers/sores (partial and full thickness);
- Wounds as an effective barrier to bacterial penetration of the dressing as this may help . reduce infection;
- Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; .
- Surgical wounds that heal by primary intention such as dermatological and surgical . incisions (e.g., orthopedic and vascular)
- . Traumatic wounds
- Wounds that are prone to bleeding, such as wounds that have been mechanically or . surgically debrided and donor sites
- Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating t carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
- Management of painful wounds .
- . Infected wounds
Device Description
Silver Hydrofiber® Reinforced with Nylon Wound Dressings is a soft, sterile, non-woven flat dressing composed of hydrocolloid fibers (sodium carboxymethylcellulose), that is reinforced with nylon stitching and that contain 1.2% ionic silver which allows for an average of 12mg of silver for a 4 inch x 4 inch dressing. The silver in the dressing kills wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of nonviable tissue from the wound (autolytic debridement). The moist wound healing environment and control of wound bacteria supports the body's healing process and helps reduce the risk of wound infection.
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K Number
K080383Device Name
AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING
Manufacturer
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C.
Date Cleared
2008-05-02
(80 days)
Product Code
FRO, NAC
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
**CONVATEC, A DIVISION OF E.R. SQUIBB **& SONS, L
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Over-the-Counter Use, AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing may be used for:
- Abrasions
- Lacerations
- Minor cuts
- Minor scalds and burns
Under the supervision of a healthcare professional, AQUACEL® Ag Hydrofiber Dressing may be used for the management of:
- Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection
- Partial thickness (second degree) burns
- Diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness)
- Surgical wounds left to heal by secondary intention such as dehisced surgical incisions
- Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular)
- Traumatic wounds
- Wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and donor sites
- Oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
- Management of painful wounds
- Infected Wounds
For Over-the-Counter Use, AQUACEL® Hydrofiber® Wound Dressing may be used for:
- Abrasions
- Lacerations
- Minor cuts
- Minor scalds and burns
Under the supervision of a healthcare professional, AQUACEL® Hydrofiber® Wound Dressing may be used for the management of:
- Leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers
- Surgical wounds (post-operative, donor sites, dermatological)
- Partial thickness (second degree) burns
- Traumatic or surgical wounds left to heal by secondary intention such as dehisced surgical incisions
- Surgical wounds that heal by primary intent, such as dermatological and surgical incisions (e.g., orthopedic and vascular)
- Traumatic wounds
- Local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites
- Management of painful wounds
Device Description
AQUACEL® Ag Hydrofiber® (Silver Impregnated Antimicrobial Dressing) is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver which allows for a maximum of 12mg of silver for a 4 inch x 4 inch dressing. The silver in the dressing kills wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). The moist wound healing environment and control of wound bacteria supports the body's healing process and helps reduce the risk of wound infection.
AQUACEL® Hydrofiber® Wound Dressings are soft, sterile, non-woven pad or ribbon dressings composed of hydrocolloid fibers (sodium carboxymethylcelulose) These conformable and highly absorbent dressings absorb wound fluids and create a soft sel which maintains a moist environment which supports the body's healing process.
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K Number
K063271Device Name
AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING
Manufacturer
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, LLC.
Date Cleared
2007-04-16
(168 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
**CONVATEC, A DIVISION OF E.R. SQUIBB **& SONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Over - the - Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, lacerations, minor cuts, and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for the management of: leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers, surgical wounds (post-operative, donor sites, dermatological), second degree burns. Aquacel may also be used for: management of surgical or traumatic wounds that have been left to heal by secondary intention, local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds, the management of painful wounds.
Device Description
AQUACEL® dressing is a soft, sterile, non-woven pad or ribbon dressing composed of hydrocolloid fibers (sodium carboxymethylcellulose).
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K Number
K013814Device Name
ABSORBENT ANTIMICROBIAL WOUND DRESSING
Manufacturer
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
Date Cleared
2002-06-21
(217 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
**CONVATEC, A DIVISION OF E.R. SQUIBB **& SONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For over-the-counter use, Absorbent Antimicrobial Wound Dressing may be used for minor abrasions, lacerations, minor cuts, minor scalds and burns.
Under the supervision of a health care professional, Absorbent Antimicrobial Wound Dressing is an effective barrier to bacterial penetration, which may help reduce infection in partial thickness (second degree) burns, diabetic foot ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness), surgical wounds left to heal by secondary intent, traumatic wounds, wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma.
Absorbent Antimicrobial Wound Dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the DIRECTIONS FOR USE.
Device Description
Absorbent Antimicrobial Wound Dressing is composed of sodium carboxymethylcellulose and ionic silver. In contact with wound exudate, the highly absorbent dressing creates a soft, cohesive gel that forms an intimate contact with the wound surface and maintains a moist woundhealing environment.
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K Number
K990964Device Name
SIGNADRESS DUODERM DRESSING
Manufacturer
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
Date Cleared
1999-05-18
(56 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
**CONVATEC, A DIVISION OF E.R. SQUIBB **& SONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For Over-The-Counter use SignaDRESS™ DuoDERM® Dressing may be used on abrasions, minor cuts, minor scalds and burns, and skin tears. Under the supervision of a health care professional, SignaDRESS may be used for wounds such as leg ulcers ( venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology), pressure ulcers (Stage I-IV) and diabetic ulcers, surgical wounds (postoperative wounds, donor sites, dermatological excisions), and burns (first and second degree).
Device Description
SignaDRESS™ DuoDERM® Dressing is a sterile hydrocolloid dressing that, over-the-counter, may be used on abrasions, lacerations, minor cuts, minor scalds and burns and skin tears. Under the supervision of a healthcare professional, SignaDRESS may be used for wounds such as leg ulcers (venous stasis ulcers, aertial ulcers and leg ulcers of mixed aetiology), pressure ulcers (Stage I-IV) and diabetic ulcers, surgical wounds (post-operative wounds, donor sites, dermatological excisions), and burns (first and second degree).
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K Number
K984388Device Name
HA ABSORBENT WOUND DRESSING
Manufacturer
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
Date Cleared
1999-03-03
(85 days)
Product Code
KGN
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
**CONVATEC, A DIVISION OF E.R. SQUIBB **& SONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For over-the-counter use, HA Absorbent Wound Dressing-F may be used for wounds such as: abrasions, lacerations, minor cuts and first degree burns. Under the supervision of a healthcare professional, HA Absorbent Wound Dressing-F may be used for wounds such as: leg ulcers, pressure ulcers (stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), second degree burns; management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.
HA Absorbent Wound Dressing-R is indicated for use in the management of deep exuding wounds, sinuses, and fistulae.
Device Description
HA Absorbent Wound Dressing is an absorbent fibrous fleece (F) or rope (R), entirely composed of HYAFF 11p757M, a benzyl ester of hyaluronic acid.
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K Number
K980720Device Name
NONWOVEN PAD
Manufacturer
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
Date Cleared
1998-04-15
(50 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
**CONVATEC, A DIVISION OF E.R. SQUIBB **& SONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ConvaTec Nonwoven Pad is intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions and excisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology.
Device Description
Nonwoven Pad is a sterile, absorbent pad dressing intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor abrasions, minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers of mixed aetiology. Nonwoven Pad absorbs wound exudate. The hydrophobic layer minimizes strike through of exudate and ensures distribution of the fluid throughout the dressing.
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K Number
K980382Device Name
NON-WOVEN COMPRESS
Manufacturer
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
Date Cleared
1998-03-09
(35 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
**CONVATEC, A DIVISION OF E.R. SQUIBB **& SONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Non-woven Compress is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers.
Device Description
Non-woven Compress is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Non-woven Compress absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.
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K Number
K974823Device Name
NONWOVEN DRESSING
Manufacturer
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
Date Cleared
1998-02-20
(58 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
**CONVATEC, A DIVISION OF E.R. SQUIBB **& SONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nonwoven Dressing is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers.
Device Description
Nonwoven Dressing is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Nonwoven Dressing absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.
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K Number
K974205Device Name
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
Manufacturer
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
Date Cleared
1998-02-06
(88 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
**CONVATEC, A DIVISION OF E.R. SQUIBB **& SONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Knitted Wound Dressing Standard, WCL and Ribbon can be used in the management of acute and chronic wounds, including diabetic ulcers. The design of Standard makes it suitable for shallow or cavity wounds and Ribbon as a packing strip for cavity wounds, fistulae and sinuses.
Device Description
Knitted Wound Dressing is a sterile gelling gauze. The warp (fibers running top to bottom) consist of viscose yarn, while the wefts (fibers running left right) are a co-spun alginate and viscose.
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