Enztec Classic Patella Clamp - TJO
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Enztec Classic Patella Clamp EUDAMEDFDA UDIEnztec Classic Patella Clamp - TJO FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Enztec Patella Instruments EUDAMEDA reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDIA reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
- Model / Reference
- 4240-4314 EUDAMEDFDA UDI2315.00.000 FDA UDI
- Description
- A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDIA reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 2315.00.000 FDA UDI4240-4314 FDA UDI
- Primary DI / UDI-DI
- 09421028111171 EUDAMEDFDA UDI09421028115490 FDA UDI
- Basic UDI-DI
- 942102811GMN0011ZT EUDAMED
- Direct Marketing DI
- 09421028111171 EUDAMED
- FDA Product Code
- HXD FDA UDI
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 FDA UDI
- 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
Enztec Classic Patella Clamp - TJO 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 (3)
- FDA UDI 194c4b5b-2eb6-4135-b11c-60afd6f97fc7 34 fields · synced Jun 20, 2026
- FDA UDI e27fffbc-1af2-42a5-a02e-bcd5fc39198e 34 fields · synced May 30, 2026
- EUDAMED 377a3e29-e704-4b51-aae8-a0b4bbb722b0 61 fields · synced Jun 20, 2026