Enztec Premium Patella Saw Guide - 8- 10mm - S+N
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Enztec Premium Patella Saw Guide - 8-10mm EUDAMEDFDA UDIEnztec Premium Patella Saw Guide - 10mm - S&N EUDAMEDEnztec Premium Patella Saw Guide - 8-10mm - S+N EUDAMEDEnztec Premium Patella Saw Guide - 8- 10mm - S+N 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 UDI
- Model / Reference
- 4240-4311 EUDAMEDFDA UDI4240-4312 EUDAMEDFDA UDI35130784 EUDAMED
- Description
- A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 4240-4311 FDA UDI4240-4312 FDA UDI
- Primary DI / UDI-DI
- 09421028115681 EUDAMEDFDA UDI09421028117722 EUDAMEDFDA UDI09421028117715 EUDAMED
- Basic UDI-DI
- 942102811GMN0011ZT EUDAMED
- Direct Marketing DI
- 09421028117722 EUDAMED09421028117715 EUDAMED09421028115681 EUDAMED
- FDA Product Code
- FZX 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
- Market of Registration
- Netherlands 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
Enztec Premium Patella Saw Guide - 8- 10mm - S+N 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 (5)
- FDA UDI 2a43a780-54fb-477f-8bf1-79d710c35666 34 fields · synced Jul 18, 2026
- FDA UDI 3455dbbf-9003-4bb1-83e4-f61ce7993294 34 fields · synced May 30, 2026
- EUDAMED 352f81e6-9382-4258-9d69-ab1affc327e0 61 fields · synced Jul 15, 2026
- EUDAMED 87360126-fcd6-4312-879a-e1aa32fb5252 61 fields · synced Jul 17, 2026
- EUDAMED 5e3f1faa-ae57-4455-a7b9-60bb73040ff4 61 fields · synced Jul 18, 2026