Identity
- Trade Name
- Ennovate® EUDAMEDENNOVATE C FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Device Name
- ENNOVATE C instrument IIa SU non-sterile EUDAMEDENNOVATE C CANUL.DRILL D2.8 F/UNIV.GUIDE FDA UDI
- Model / Reference
- SZ014R EUDAMEDFDA UDI
- Description
- ENNOVATE C CANUL.DRILL D2.8 F/UNIV.GUIDE FDA UDI
Identifiers
- Catalog Number
- SZ014R FDA UDI
- Primary DI / UDI-DI
- 04046955624768 EUDAMEDFDA UDI
- Basic UDI-DI
- 40392390000026262V EUDAMED
- FDA Product Code
- NKG FDA UDI
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.3075 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
Ennovate C by Aesculap, Inc. — Class II — 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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Aesculap, Inc.
Sources (2)
- FDA UDI f8757544-21af-495d-a3bf-88cfcaba1d65 35 fields · synced Oct 8, 2026
- EUDAMED b6788030-c9fb-4f44-80e8-e777144954d6 61 fields · synced Oct 8, 2026