Identity
- Trade Name
- UCP Stem EUDAMEDFDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- United Hip and Knee Non-sterile Reusable Instruments EUDAMEDUCP Stem case #2 FDA UDI
- Model / Reference
- 9107-8120-RA EUDAMEDFDA UDI
- Description
- UCP Stem case #2 FDA UDI
Identifiers
- Catalog Number
- 9107-8120-RA FDA UDI
- Primary DI / UDI-DI
- 04711605582766 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987216TD-Ir-003F4 EUDAMED
- Direct Marketing DI
- 04711605582766 EUDAMED
- 510(k) Number
- K152530 FDA UDI
- FDA Product Code
- KWY FDA UDILWJ FDA UDIJDI FDA UDILZO FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3390 FDA UDI888.3360 FDA UDI888.3350 FDA UDI888.3353 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
UCP Stem by United Orthopedic Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987216TD-Ir-003F4 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- United Orthopedic Corporation
- EUDAMED SRN
- TW-MF-000009523
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED d661134a-1af0-4c85-8b86-26b6d904ea67 61 fields · synced Jun 9, 2026
- FDA UDI a91f81a9-2357-4554-9f3b-132d8f3b2291 36 fields · synced May 27, 2026