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Silver-sept Silver Antimicrobial Skin and Wound Gel
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- Silver-sept Silver Antimicrobial Skin and Wound Gel FDA UDI
- Generic Name
- Wound hydrogel dressing, antimicrobial FDA UDI
- Device Name
- Silver-sept® Silver Antimicrobial Skin and Wound Gel, containing 200ug/gram total silver, is a clear amorphous hydrogel wound dressing. Silver-sept will not stain or discolor tissue. Silver-sept® gel functions as a long-lasting antimicrobial barrier by inhibiting the growth of common bacteria such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens including the antibiotic resistant strains Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE) as well as fungi such as Candida albicans and Aspergillus niger. FDA UDI
- Model / Reference
- 3003S FDA UDI
- Description
- Silver-sept® Silver Antimicrobial Skin and Wound Gel, containing 200ug/gram total silver, is a clear amorphous hydrogel wound dressing. Silver-sept will not stain or discolor tissue. Silver-sept® gel functions as a long-lasting antimicrobial barrier by inhibiting the growth of common bacteria such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens including the antibiotic resistant strains Methicillin resistant Staphylococcus aureus (MRSA), Vancomycin resistant Enterococcus faecalis (VRE) as well as fungi such as Candida albicans and Aspergillus niger. FDA UDI
Identifiers
- Catalog Number
- 3003S FDA UDI
- Primary DI / UDI-DI
- 00367180300031 FDA UDI
- 510(k) Number
- K062212 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound hydrogel dressing, antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 86 Gram FDA UDI
Category: Wound hydrogel dressing, antimicrobial
Silver-sept Silver Antimicrobial Skin and Wound Gel by Anacapa Technologies, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound hydrogel dressing, antimicrobial.
- Pure&Clean — Pure & Clean, LLC · U
- EltaMD SilverGel 1.5 oz — CP Skin Health Group, Inc. · U
- BlastX™ — Next Science LLC · U
- ProCure — Twin Med, LLC · U
- Armor Gel — Abl Medical, LLC · U
- L-Mesitran Hydro — Theo Manufacturing B.V. · U
- Anasept Antimicrobial Skin and Wound Gel filled in 3 oz. tube with dispensing ca — ARGENTUM MEDICAL, LLC · U
- Carestat — American Biotech Labs · U
Cleared under the same submission
K062212 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Anacapa Technologies, Inc.
Sources (1)
- FDA UDI a5087285-0702-49e1-a55a-3e1932867083 38 fields · synced May 30, 2026