Identity
- Trade Name
- Orthopaedic Surgical Instruments FDA UDI
- Generic Name
- Orthopaedic bone-fragment manipulator, single-use, non-sterile FDA UDI
- Model / Reference
- Fracture alignment guide wire exchange tool FDA UDI
Identifiers
- Catalog Number
- DT010020 FDA UDI
- Primary DI / UDI-DI
- 08032909622009 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic bone-fragment manipulator, single-use, non-sterile 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: Orthopaedic bone-fragment manipulator, single-use, non-sterile
Orthopaedic Surgical Instruments by Citieffe — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Citieffe
Sources (1)
- FDA UDI 84dd52f2-f927-4b49-a7b7-8403f9c5e72d 34 fields · synced Jun 1, 2026