Identity
- Trade Name
- SURGICAL STERILE DRAPE FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- LIQUID REPELLENT DRAPE CM 133X200 WITH ADHESIVE U SHAPE CM 6,5X50 AND LOOP - SONTARA - BLUE FDA UDI
- Model / Reference
- 12.T1792.00 FDA UDI
- Description
- LIQUID REPELLENT DRAPE CM 133X200 WITH ADHESIVE U SHAPE CM 6,5X50 AND LOOP - SONTARA - BLUE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056646502127 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Patient surgical drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Surgical Sterile Drape by Omnia Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 II | Pending data |
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Manufacturer
- Manufacturer
- Omnia Spa
Sources (1)
- FDA UDI 322b3155-b7ff-4f28-8ac5-02fea3269515 35 fields · synced Jun 8, 2026