Identity
- Trade Name
- UCP Stem EUDAMEDUCP™ Stem FDA UDI
- Generic Name
- Orthopaedic broach FDA UDI
- Device Name
- United Hip and Knee Non-sterile Reusable Instruments EUDAMEDUCP Stem broach, #2, 180mm FDA UDI
- Model / Reference
- 9107-6421 EUDAMEDFDA UDI
- Description
- UCP Stem broach, #2, 180mm FDA UDI
Identifiers
- Catalog Number
- 9107-6421 FDA UDI
- Primary DI / UDI-DI
- 04719872167631 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987216TD-Ir-003F4 EUDAMED
- Direct Marketing DI
- 04719872167631 EUDAMED
- 510(k) Number
- K152530 FDA UDI
- FDA Product Code
- LWJ FDA UDIJDI FDA UDIKWY FDA UDILZO FDA UDI
- EMDN Code
- L091202 ORTHOPAEDIC SURGERY FILES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic broach FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3360 FDA UDI888.3350 FDA UDI888.3390 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 |
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Manufacturer
- Manufacturer
- United Orthopedic Corporation
- EUDAMED SRN
- TW-MF-000009523
- Authorised Representative
- mdi Europa GmbH DE-AR-000006218
Sources (2)
- EUDAMED 4de652b2-c1ce-426e-b258-44099ca4bf87 61 fields · synced Jul 12, 2026
- FDA UDI 90f66db1-71d1-47d0-a2b8-b89482128929 37 fields · synced May 30, 2026