Identity
- Trade Name
- 3M™ Silvercel™ FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- 3M™ Silvercel™ Non-Adherent Antimicrobial Alginate Dressing, 900112, 1 in x 12 in, Rope, 5/Ct, 5 Cts/Cs FDA UDI
- Model / Reference
- 900112 FDA UDI
- Description
- 3M™ Silvercel™ Non-Adherent Antimicrobial Alginate Dressing, 900112, 1 in x 12 in, Rope, 5/Ct, 5 Cts/Cs FDA UDI
Identifiers
- Catalog Number
- 900112 FDA UDI
- Primary DI / UDI-DI
- 25032749039446 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
No
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
3M™ Silvercel™ by 3M Deutschland GmbH — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Exudate-absorbent dressing, hydrophilic-gel, antimicrobial.
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- ActivHeal — ADVANCED MEDICAL SOLUTIONS LIMITED · U
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Cleared under the same submission
K081363 also covers:
- 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
- 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
- 3M Deutschland GmbH
Sources (1)
- FDA UDI 6aa22442-a359-461d-9202-96a214770ca6 36 fields · synced May 30, 2026