Identity
- Trade Name
- ELITE FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- ELITE CUP OGEE - CEMENTED LPW 32mmID 50mmOD FDA UDI
- Model / Reference
- 9625-18-000 FDA UDI
- Description
- ELITE CUP OGEE - CEMENTED LPW 32mmID 50mmOD FDA UDI
Identifiers
- Catalog Number
- 962518000 FDA UDI
- Primary DI / UDI-DI
- 10603295318071 FDA UDI
- 510(k) Number
- K940743 FDA UDI
- FDA Product Code
- LZN FDA UDIJDB FDA UDIKWI FDA UDIKWY FDA UDIHRY FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 FDA UDI888.3160 FDA UDI888.3170 FDA UDI888.3390 FDA UDI888.3530 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Elite by Depuy International 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
- Depuy International Ltd
Sources (1)
- FDA UDI e0f657b0-580a-43d4-b2a5-85352c51aca9 37 fields · synced May 31, 2026