Identity
- Trade Name
- U1 Total Hip System FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Cup reamer handle FDA UDI
- Model / Reference
- 9203-1201-TD FDA UDI
- Description
- Cup reamer handle FDA UDI
Identifiers
- Catalog Number
- 9203-1201-TD FDA UDI
- Primary DI / UDI-DI
- 04719886907209 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
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: Surgical instrument handle, non-torque-limiting
U1 Total Hip System by United Orthopedic Corp. — Class I — MDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical instrument handle, non-torque-limiting.
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- Tecomet — Tecomet,Inc · Class I
- Equinoxe — Exactech, Inc. · Class II
- Kinectiv® — Zimmer, Inc. · Class I
- CUSTOM U JOINT DRIVER — Zimmer, Inc. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- United Orthopedic Corp.
Sources (2)
- FDA UDI 63d6f505-03b2-467d-9501-6fe09be83bc1 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced May 29, 2026