Enztec Premium Patella Saw Guide – 10mm (1.37mm Blade)
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Enztec Premium Patella Saw Guide - 10mm EUDAMEDFDA UDIEnztec Premium Patella Saw Guide – 10mm (1.37mm Blade) FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusable FDA UDI
- Device Name
- Enztec Patella Instruments EUDAMEDA reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDIA reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
- Model / Reference
- 4240-4310 EUDAMEDFDA UDI4240-4410 FDA UDI
- Description
- A reusable surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDIA reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 4240-4410 FDA UDI4240-4310 FDA UDI
- Primary DI / UDI-DI
- 09421028111232 EUDAMEDFDA UDI09421028118743 FDA UDI
- Basic UDI-DI
- 942102811GMN0011ZT EUDAMED
- Direct Marketing DI
- 09421028111232 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
- 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
Enztec Premium Patella Saw Guide – 10mm (1.37mm Blade) 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 04d1d0e2-ce5a-4835-86b3-bea45a489bde 34 fields · synced Jul 9, 2026
- FDA UDI a9242a2c-2663-4079-ac72-4b508fa5dd38 34 fields · synced May 30, 2026
- EUDAMED be3dda24-8762-4e77-8ab0-f6fd23793d91 61 fields · synced Jul 9, 2026