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510(k) Data Aggregation
K Number
K241809Device Name
coactiv+ Antimicrobial Wound Gel
Manufacturer
Kane Biotech, Inc.
Date Cleared
2024-07-19
(28 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Kane Biotech, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx: The coactiv+™ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds and surgical incisions for adult populations.
OTC: The coactiv+™ Antimicrobial Wound Gel is indicated for management of minor lacerations, minor burns (1st degree burns) and abrasions for adult populations.
Device Description
The coactiv+™ Antimicrobial Wound Gel is a white, odorless gel that provides a moist wound environment conducive to wound healing. The coactiv+™ Antimicrobial Wound Gel provides preservative properties through an antimicrobial (PHMB) to help inhibit microbial colonization within the gel during shelf storage. Chronic wounds are known to contain non-viable tissue. The coactiv+™ Antimicrobial Wound Gel can facilitate debridement through a moist wound environment.
The coactiv+™ Antimicrobial Wound Gel contains water, Poloxamer 407, Glycerol, Trisodium citrate, PHMB (0.1% w/w), Citric acid, Disodium EDTA.
The coactiv+™ Antimicrobial Wound Gel dressing will be supplied in 0.7 oz. (21 g) white/opaque polypropylene (19 x 100 mm) screw cap tubes.
The device will be available as both a Rx and OTC product.
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K Number
K223259Device Name
coactiv+ Antimicrobial Wound Gel
Manufacturer
Kane Biotech, Inc.
Date Cleared
2023-05-24
(212 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Kane Biotech, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx: The coactiv+™ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds, large surface area wounds and surgical incisions for adult populations.
OTC: The coactiv+™ Antimicrobial Wound Gel is indicated for management of minor lacerations, minor burns (1st degree burns) and abrasions for adult populations.
Device Description
The coactiv+™ Antimicrobial Wound Gel is a white, odorless hydrogel that provides a moist wound environment conducive to wound healing. The coactiv+™ Antimicrobial Wound Gel provides preservative properties through an antimicrobial (PHMB) to help inhibit microbial colonization within the gel during shelf storage. Chronic wounds are known to contain non-viable tissue. The coactiv+™ Antimicrobial Wound Gel can facilitate debridement through a moist wound environment.
The coactiv+™ Antimicrobial Wound Gel contains water, Poloxamer 407, Glycerol, Trisodium citrate, PHMB (0.1% w/w), Citric acid, Disodium EDTA.
The coactiv+™ Antimicrobial Wound Gel dressing will be supplied in 0.7 oz. (21 g) white/opaque polypropylene (19 x 100 mm) screw cap tubes.
The device will be available as both a Rx and OTC product.
Ask a Question
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