Identity
- Trade Name
- Biatain Silicone Ag FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, antimicrobial FDA UDI
- Model / Reference
- 39638 FDA UDI
Identifiers
- Catalog Number
- 39638 FDA UDI
- Primary DI / UDI-DI
- 05708932730549 FDA UDI
- 510(k) Number
- K191536 FDA UDI
- FDA Product Code
- FRO FDA UDI
- GMDN Term
- Exudate-absorbent dressing, non-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
Dimensions & Sizes
- Size
- Length — 12.5 Centimeter FDA UDILength — 5 Inch FDA UDIWidth — 5 Inch FDA UDIWidth — 12.5 Centimeter FDA UDI
Category: Exudate-absorbent dressing, non-gel, antimicrobial
Biatain Silicone Ag by Coloplast A/S — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent dressing, non-gel, antimicrobial.
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- Medline — MEDLINE INDUSTRIES, INC. · U
- NuMed Industries LLC. — Numed Industries, LLC · U
- Arthrex® — Arthrex, Inc. · U
- CalciCare — Hollister Incorporated · U
- ComfortFoam/Ag Border — DERMARITE INDUSTRIES LLC · U
Cleared under the same submission
K191536 also covers:
- Biatain Silicone Ag — Coloplast A/S
- Biatain Silicone Ag — Coloplast A/S
- Biatain Silicone Ag — Coloplast A/S
- Biatain Silicone Ag — Coloplast A/S
- Biatain Silicone Ag — Coloplast A/S
- Biatain Silicone Ag — Coloplast A/S
- Biatain Silicone Ag Heel — Coloplast A/S
- Biatain Silicone Ag Sacral — Coloplast A/S
- Biatain Silicone Ag Sacral — Coloplast A/S
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI 5e5472ce-2f26-45b9-806e-02a166c9e62c 37 fields · synced May 30, 2026