Enztec Premium Patella Saw Guide - 9mm - S&N
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Enztec Premium Patella Saw Guide - 9mm EUDAMEDFDA UDIEnztec Premium Patella Saw Guide - 9mm - S&N EUDAMEDEnztec Premium Patella Saw Guide - 9mm - 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
- 35130488 EUDAMEDFDA UDI4240-4309 EUDAMEDFDA UDI
- Description
- A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure FDA UDI
Identifiers
- Catalog Number
- 35130488 FDA UDI4240-4309 FDA UDI
- Primary DI / UDI-DI
- 09421028117708 EUDAMEDFDA UDI09421028111225 EUDAMEDFDA UDI
- Basic UDI-DI
- 942102811GMN0011ZT EUDAMED
- Direct Marketing DI
- 09421028111225 EUDAMED09421028117708 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
- Italy 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 - 9mm - 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 (4)
- FDA UDI 3e48ea0d-de6e-4013-b20b-bf5e5e9c59a9 34 fields · synced Jul 14, 2026
- FDA UDI 180d1d2c-01a1-4897-b475-f38e3ec6ef2c 34 fields · synced May 30, 2026
- EUDAMED 0bd8695e-5088-4fc7-82d7-0278bc00b6ce 61 fields · synced Jul 11, 2026
- EUDAMED ce4ccd01-e6ef-4666-8e59-e724f116cf67 61 fields · synced Jul 14, 2026