Identity
- Trade Name
- CHARNLEY FDA UDI
- Generic Name
- Uncoated hip femur prosthesis, one-piece FDA UDI
- Device Name
- CHARNLEY STEM FLANGED 40 22.225mm OD HEAD CEMENTED FDA UDI
- Model / Reference
- 9622-97-000 FDA UDI
- Description
- CHARNLEY STEM FLANGED 40 22.225mm OD HEAD CEMENTED FDA UDI
Identifiers
- Catalog Number
- 962297000 FDA UDI
- Primary DI / UDI-DI
- 10603295241881 FDA UDI
- 510(k) Number
- K802627 FDA UDI
- FDA Product Code
- JDI FDA UDI
- GMDN Term
- Uncoated hip femur prosthesis, one-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 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
Charnley 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 34b8df1c-6618-413c-aa89-00217092f04e 37 fields · synced May 30, 2026