Identity
- Trade Name
- Adhesive film FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- STERILE PROTECT. FILM (10/pkg) - Bien Air FDA UDI
- Model / Reference
- 32.U0026.00 FDA UDI
- Description
- STERILE PROTECT. FILM (10/pkg) - Bien Air FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056646503919 FDA UDI
- FDA Product Code
- FXT FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4160 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical equipment/instrument drape, single-use
Adhesive film by Omnia Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medical equipment/instrument drape, single-use.
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- Probe Cover — Advance Medical Designs, Inc. · Class II
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
- Omnia Spa
Sources (1)
- FDA UDI c9dad192-a498-4a15-9219-c0f2d1b8efca 33 fields · synced Jun 1, 2026