Identity
- Trade Name
- U2 Hip Stem EUDAMEDU2™ Hip FDA UDI
- Generic Name
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
- Device Name
- United Hip and Knee Non-sterile Reusable Instruments EUDAMEDFull PE cement restrictor inserter FDA UDI
- Model / Reference
- 9104-1102 EUDAMEDFDA UDI
- Description
- Full PE cement restrictor inserter FDA UDI
Identifiers
- Catalog Number
- 9104-1102 FDA UDI
- Primary DI / UDI-DI
- 04719872171614 EUDAMEDFDA UDI
- Basic UDI-DI
- 471987216TD-Ir-003F4 EUDAMED
- Direct Marketing DI
- 04719872171614 EUDAMED
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 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
Yes
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
Category: Orthopaedic implant impactor, reusable
U2 Hip Stem by United Orthopedic Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant impactor, reusable.
- TRIAL COVERING INSERT Ø32 48 — groupe lépine · Class IIa
- MobiliT Cup — CORIN LTD · Class II
- R3 — Smith & Nephew, Inc. · Class II
- TRIAL COVERING INSERT Ø28 39 — groupe lépine · Class IIa
- MobiliT Cup — CORIN LTD · Class II
- KMEDIC — TELEFLEX INCORPORATED · Class I
- TRIAL COVER INSERT Ø28 36 — groupe lépine · Class IIa
- R3 — Smith & Nephew, Inc. · Class I
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 950ed363-5d72-4943-86dc-d65e6722a411 61 fields · synced Jul 9, 2026
- FDA UDI a246639e-032d-46fe-b583-65fb2cd68398 35 fields · synced May 30, 2026