Search Results
Found 1 results
510(k) Data Aggregation
K Number
K222025Device Name
G4Derm / G4Derm Plus Synthetic Wound Matrix
Manufacturer
Gel4Med, Inc.
Date Cleared
2023-10-11
(457 days)
Product Code
FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Gel4Med, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OTC: May be used for superficial wounds and abrasions and minor burns.
Rx: Under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first-degree and partial-thickness burns including management of abrasions and burns associated with dermabrasions and laser resurfacing.
Device Description
G4Derm / G4Derm Plus Synthetic Wound Matrix is a sterile, biodegradable hydrogel matrix supplied in a prefilled syringe ready for topical use as primary wound dressing, with or without the use of an optional nozzle. The hydrogel in G4Derm / G4Derm Plus is composed of an aqueous solution of synthetic peptide (≥ 98% sterile water). The device is completely non-animal tissue and non-cellular derived.
G4Derm / G4Derm Plus forms a three-dimensional hydrogel scaffold, which, at a basic structural level, is composed of a matrix of interwoven fibrils formed from individual peptide monomers. This woven network structure, or matrix barrier, is similar to the microarchitecture of endogenous extracellular matrix ("ECM"). This structure also functions as a matrix that holds and donates water to underlying tissue, while providing an effective barrier to cover and protect the wound against the external environment, namely against bacterial penetration.
G4Derm / G4Derm Plus Synthetic Wound Matrix forms a clear, biodegradable hydrogel without expansion in volume. During dressing changes, the unincorporated or unintegrated material may be removed without causing trauma to the underlying tissue by gently flushing / wiping the wound.
Ask a Question
Page 1 of 1