Identity
- Trade Name
- OMNISLEEVE FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- sterile and disposable protective barriers in water-repellent TNT, PVC, latex and polyurethane for the treatment center, the quiver, the lamp handles, the control panels, the switches, the handpieces, the suction tubes, the end part of the X-rays , cameras, trays and instrument holders, contaminated waste containers, basins and swabs for disinfection. FDA UDI
- Model / Reference
- 22.U0001.00 FDA UDI
- Description
- sterile and disposable protective barriers in water-repellent TNT, PVC, latex and polyurethane for the treatment center, the quiver, the lamp handles, the control panels, the switches, the handpieces, the suction tubes, the end part of the X-rays , cameras, trays and instrument holders, contaminated waste containers, basins and swabs for disinfection. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056646502561 FDA UDI
- FDA Product Code
- NRD FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6640 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Medical equipment/instrument drape, single-use
Omnisleeve by Omnia Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 0e6da818-2419-4817-9c28-449e571a1d0a 33 fields · synced Jun 8, 2026