Identity
- Trade Name
- Unity ASC - Down Rod EUDAMEDFDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Tibial Alignment Guides EUDAMEDA reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
- Model / Reference
- 1232151 EUDAMEDFDA UDI
- Description
- A reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 1232151 FDA UDI
- Primary DI / UDI-DI
- 09421028113052 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN003226 EUDAMED
- Direct Marketing DI
- 09421028113052 EUDAMED
- FDA Product Code
- FZX FDA UDI
- EMDN Code
- L0922 ORTHOPAEDIC SURGERY GUIDES, REUSABLE EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic prosthesis implantation positioning instrument, reusable
Unity ASC - Down Rod by Enztec Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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
- Enztec Limited
Sources (2)
- FDA UDI d11edd58-23e0-4481-b34f-2489dc44c705 34 fields · synced Jul 10, 2026
- EUDAMED 7b62bab9-daba-446f-854f-9b87ab710101 61 fields · synced Jul 10, 2026