Identity
- Trade Name
- Biatain Silicone Non-Border FDA UDI
- Generic Name
- Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI
- Device Name
- Biatain Silicone Non-Border . Non-Border foam dressing - with soft adhesion for general purposes. Klinikpackung. Dressing Length 10 cm, Dressing Length 4 in, Dressing Width 10 cm, Dressing Width 4 in. FDA UDI
- Model / Reference
- 39022 FDA UDI
- Description
- Biatain Silicone Non-Border . Non-Border foam dressing - with soft adhesion for general purposes. Klinikpackung. Dressing Length 10 cm, Dressing Length 4 in, Dressing Width 10 cm, Dressing Width 4 in. FDA UDI
Identifiers
- Catalog Number
- 39022 FDA UDI
- Primary DI / UDI-DI
- 05701780210652 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 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
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Centimeter FDA UDILength — 4 Inch FDA UDIWidth — 4 Inch FDA UDIWidth — 10 Centimeter FDA UDI
Category: Exudate-absorbent dressing, non-gel, non-antimicrobial
Biatain Silicone Non-Border by Coloplast A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Exudate-absorbent dressing, non-gel, non-antimicrobial.
- ALLEVYN Gentle Border Sacrum Large — Smith & Nephew Medical, Ltd. · Class I
- ULTRA Border — MILLIKEN HEALTHCARE PDTS, LLC · Class I
- NuVeria Labs — REMEDIUM HEALTHCARE PRODUCTS · Class I
- KerraFoam Simple — CRAWFORD HEALTHCARE LIMITED · Class I
- CovaWound™ Foam 5x5 — Covalontechnologies, Inc. · Class I
- Allevyn Life — Smith & Nephew Medical, Ltd. · Class I
- ComfortFoam Border Sacral Healogics by DermaRite — DERMARITE INDUSTRIES LLC · Class I
- 3M™ Tegaderm™ — 3M COMPANY · Class I
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 |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI eaa838b6-4cc7-419b-bcc3-406fe6ffc4d0 37 fields · synced May 30, 2026