Identity
- Trade Name
- EltaMD SilverGel 8 oz FDA UDI
- Generic Name
- Wound hydrogel dressing, antimicrobial FDA UDI
- Device Name
- This clear, amorphous antimicrobial wound gel is designed to provide a moist healing environment and to help control bioburden. FDA UDI
- Model / Reference
- 02528 FDA UDI
- Description
- This clear, amorphous antimicrobial wound gel is designed to provide a moist healing environment and to help control bioburden. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00390205025282 FDA UDI
- 510(k) Number
- K071703 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Wound hydrogel dressing, antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
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
EltaMD SilverGel 8 oz by CP Skin Health Group, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K071703 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
- CP Skin Health Group, Inc.
Sources (1)
- FDA UDI 03769e16-6c15-4702-ac23-0742330d97c4 36 fields · synced Jun 8, 2026