Identity
- Trade Name
- Gentell FDA UDI
- Generic Name
- Wound hydrogel dressing, non-antimicrobial FDA UDI
- Device Name
- Hydrogel Sheet Dressing 4.7"x3.4" FDA UDI
- Model / Reference
- GEN-11470 FDA UDI
- Description
- Hydrogel Sheet Dressing 4.7"x3.4" FDA UDI
Identifiers
- Catalog Number
- GEN-11470 FDA UDI
- Primary DI / UDI-DI
- 00361554005638 FDA UDI
- FDA Product Code
- NAE FDA UDI
- GMDN Term
- Wound hydrogel dressing, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4022 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Gentell by Gentell — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gentell
Sources (1)
- FDA UDI 9f71e8bc-e4b2-4c33-94fc-fb5b62b4f40e 35 fields · synced Jun 8, 2026