Identity
- Trade Name
- Tegaderm FDA UDI
- Generic Name
- Exudate-absorbent dressing, hydrophilic-gel, antimicrobial FDA UDI
- Device Name
- 14-24AP Silver Alginate II FDA UDI
- Model / Reference
- Alginate Ag FDA UDI
- Description
- 14-24AP Silver Alginate II FDA UDI
Identifiers
- Catalog Number
- 90307 FDA UDI
- Primary DI / UDI-DI
- 00707387583620 FDA UDI
- 510(k) Number
- K090453 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
Tegaderm by Advanced Medical Solutions Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K090453 also covers:
- Tegaderm™ — 3M COMPANY
- Tegaderm™ — 3M COMPANY
- Tegaderm™ — 3M COMPANY
- Tegaderm™ — 3M COMPANY
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN — ADVANCED MEDICAL SOLUTIONS LIMITED
- BIATAIN Alginate Ag — 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 278bd3ec-7679-431e-915d-b0a148e0f7e7 36 fields · synced Jun 1, 2026