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510(k) Data Aggregation
K Number
K153565Device Name
DONASORB SILVER WOUND DRESSING
Manufacturer
VIRCHOW BIOTECH PVT. LTD.
Date Cleared
2016-09-22
(283 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
VIRCHOW BIOTECH PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTC: DONASORB™ is intended for use in management of minor cuts, minor abrasions, minor lacerations and minor burns.
Rx: DONASORB™ is intended for use by prescription for the management of partial and full thickness wounds such as pressure ulcers, vascular ulcers, diabetic wounds, lacerations, abrasions, surgical wounds, graft sites, skin tears, and first and second degree burns. DONASORB™ is not indicated for use on third degree burns.
Device Description
DONASORB™ is a moist hydrogel sheet containing the antimicrobial ionic silver in the form of silver chloride which is intended to be a primary wound contact dressing to manage wound moisture. The base matrix of the subject device is composed of crosslinked polyacrylate sheet incorporating antimicrobial ionic silver in a silver chloride reservoir. Ionic silver in the form of silver chloride in the sheet inhibits the growth of broad spectrum microbes on or within the dressing. The Device is a sterile single use dressing supplied on PVC (Poly Vinyl Chloride) transparent carrier sheet, packed in a medical grade heat sealed aluminum foil pouch. Five single piece pouches are packed in a Mono-carton along with a package insert. Barrier and Antimicrobial Effectiveness was demonstrated to last for up to 2 days per bench testing. It is recommend to use DONASORB™ for up to 2 days or should be removed gently when completely saturated with wound fluids; whichever occurs first. It is available in sterile sheets of 2x2 cm, 2x4 cm, 4x8 cm, 8x8 cm and 10x10 cm sizes.
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K Number
K132326Device Name
IONSIL GEL
Manufacturer
VIRCHOW BIOTECH PVT. LTD.
Date Cleared
2014-08-21
(391 days)
Product Code
FRO, MGQ
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
VIRCHOW BIOTECH PVT. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTC: For minor wounds, minor ulcerations, minor abrasions, minor surgical wounds and minor skin irritations.
Device Description
IONSIL GEL™ is a moist amorphous hydrophilic silver chloride gel designed to act as a barrier for wounds, as a moist wound dressing. The viscous hydrogel of the device contains silver in the form of silver chloride which acts as a self preservative that inhibits the growth of broad spectrum of micro organisms in the dressing.
The product is available in a 1.5 oz (45 gm) polyethylene heat sealed tube container. The tubes will be packed in a cardboard box.
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