Identity
- Trade Name
- SILVERCEL FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- 14-24APX Silver Hydro - Alginate FDA UDI
- Model / Reference
- Silver Alginate FDA UDI
- Description
- 14-24APX Silver Hydro - Alginate FDA UDI
Identifiers
- Catalog Number
- 800112 FDA UDI
- Primary DI / UDI-DI
- 15051978002390 FDA UDI
- 510(k) Number
- K081363 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Over-the-Counter
No
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
MR Unsafe FDA UDI
Category: Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Silvercel by Advanced Medical Solutions Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent dressing, hydrophilic-gel, antimicrobial.
- DermaGinate/Ag — DERMARITE INDUSTRIES LLC · U
- AQUACEL AG+ — CONVATEC, PURCHASING DEPARTMENT · U
- 3M™ Silvercel™ — 3M Deutschland GmbH · U
- Algitocare Sterile Silver Alginate Wound Dressing — QINGDAO BRIGHT MOON BIOMATERIALCO., LTD. · U
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · U
- exsalt CMC Gelling Fiber Dressing — Exciton Technologies Inc · U
- Calcium Alginate Ag Dressing 6"x6" — Gentell · U
- Simpurity — SAFE N SIMPLE LLC · U
Cleared under the same submission
K081363 also covers:
- 3M™ Silvercel™ — 3M Deutschland GmbH
- 3M™ Silvercel™ — 3M Deutschland GmbH
- 3M™ Silvercel™ — 3M Deutschland GmbH
- 3M™ Silvercel™ — 3M Deutschland GmbH
- SILVERCEL — ADVANCED MEDICAL SOLUTIONS LIMITED
- SILVERCEL — ADVANCED MEDICAL SOLUTIONS LIMITED
- SILVERCEL — ADVANCED MEDICAL SOLUTIONS LIMITED
- SILVERCEL — ADVANCED MEDICAL SOLUTIONS LIMITED
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
- Advanced Medical Solutions Limited
Sources (1)
- FDA UDI ba00be0c-5d45-41a4-b766-600c5a8a66f3 35 fields · synced Jun 6, 2026