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Found 5 results
510(k) Data Aggregation
K Number
K151182Device Name
LiquiBand Exceed
Manufacturer
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
Date Cleared
2015-10-26
(175 days)
Product Code
MPN
Regulation Number
878.4010Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LiquiBand Exceed topical skin adhesive 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 Exceed topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Device Description
LiquiBand Exceed 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 Exceed topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand Exceed topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand Exceed topical skin adhesive polymerizes within minutes.
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K Number
K133443Device Name
MARATHON NO STING LIQUID SKIN PROTECTANT
Manufacturer
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
Date Cleared
2014-07-10
(240 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Marathon No Sting Liquid Skin Protectant is intended to protect intact or damaged skin from the effects of moisture, friction, (rubbing) or shear (tearing).
Marathon No Sting Liquid Skin Protectant helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage. Marathon No Sting Liquid Skin Protectant can also be used in areas that are exposed to friction and shear from bedding, clothing, shoes, or any material that will rub against the skin. Marathon No Sting Liquid Skin Protectant helps protect the skin against irritation caused by adhesive products.
Device Description
Not Found
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K Number
K132243Device Name
BARLE TISSUE ADHESIVE 2
Manufacturer
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
Date Cleared
2013-12-20
(155 days)
Product Code
MPN
Regulation Number
878.4010Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Barle Tissue Adhesive 2 topical skin adhesive 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. Barle Tissue Adhesive 2 topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Device Description
Barle Tissue Adhesive 2 is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure. It is applied to easily approximated skin edges and polymerizes within minutes. Barle Tissue Adhesive 2 is supplied in a single patient use configuration.
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K Number
K123133Device Name
BARLE TISSUE ADHESIVE
Manufacturer
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
Date Cleared
2013-05-22
(230 days)
Product Code
MPN, COM
Regulation Number
878.4010Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Barle Tissue Adhesive topical skin adhesive 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. Barle Tissue Adhesive topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Device Description
Barle Tissue Adhesive is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure. Barle Tissue Adhesive is supplied in a single patient use configuration. The applicator is composed of a crushable glass ampoule contained within a plastic polypropylene applicator. The ampoule is crushed through force applied by the clinician to the 'wings' of the applicator body. It is applied to easily approximated skin edges and polymerizes within minutes. The device is contained within a PET/tyvek blister.
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K Number
K122446Device Name
LIQUIDBAND FLOW CONTROL
Manufacturer
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
Date Cleared
2012-10-26
(77 days)
Product Code
MPN
Regulation Number
878.4010Why did this record match?
Applicant Name (Manufacturer) :
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LiquiBand Flow Control topical skin adhesive 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 Flow Control topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Device Description
LiquiBand® Flow Control is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate for wound closure. LiquiBand® Flow Control is supplied in a single patient use configuration. The applicator is composed of a crushable glass ampoule contained within a plastic polypropylene applicator. The ampoule is crushed through force applied by the clinician to the 'wings' of the applicator body. It is applied to easily approximated skin edges and polymerizes within 30 seconds. The device is contained within a PET/tyvek blister
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