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Replacement Kit, Surgical System Sterile Sleeve, 10 Pack
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Replacement Kit, Surgical System Sterile Sleeve, 10 Pack FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Model / Reference
- KIT0704-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290109180434 FDA UDI
- FDA Product Code
- OLO FDA UDIHAW FDA UDILLZ FDA UDI
- GMDN Term
- Patient surgical drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI892.2050 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
Yes
FDA UDI
Combination Product
No
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
Replacement Kit, Surgical System Sterile Sleeve, 10 Pack by Mazor Robotics Ltd — 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
- Mazor Robotics Ltd
Sources (1)
- FDA UDI 4edc62b6-9d0e-4559-9105-15aa5c6f5dce 34 fields · synced May 30, 2026