Identity
- Trade Name
- Cervical Trial 4 x 14 mm 12° short EUDAMEDBEE FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Cervical Trial EUDAMEDAll instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques. FDA UDI
- Model / Reference
- I091 EUDAMEDCervical Trial 4 x 14 mm 12° short FDA UDI
- Description
- All instruments provided by NGMedical are reusable surgical instruments with the purpose of enabling the implantation of an NGMedical implant. The surgical technique of each implant describes the instruments to be used. The instruments may only be used in direct connection with implants from NGMedical and as described in the respective surgical techniques. FDA UDI
Identifiers
- Catalog Number
- I091 FDA UDI
- Primary DI / UDI-DI
- 04251631417262 EUDAMED04251631411956 EUDAMEDFDA UDI04251631418962 EUDAMED
- Basic UDI-DI
- 42516314TD020IIa4W EUDAMED
- Direct Marketing DI
- 04251631417262 EUDAMED04251631411956 EUDAMED04251631418962 EUDAMED
- 510(k) Number
- K200429 FDA UDI
- FDA Product Code
- LXH FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Cervical Trial 4 x 14 mm 12° short by NGMedical GmbH — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42516314TD020IIa4W | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- NGMedical GmbH
- EUDAMED SRN
- DE-MF-000000204
Sources (4)
- EUDAMED 6fdac0cb-d150-40de-8900-866246f11e8a 61 fields · synced Oct 7, 2026
- EUDAMED 7cfea75e-5266-4b9d-9ce5-266fa6e5b052 61 fields · synced May 17, 2026
- EUDAMED f63be7fe-37ab-47db-a902-912a196df11b 61 fields · synced May 19, 2026
- FDA UDI e27403ed-66e2-4952-aed8-b77f0743a2d8 35 fields · synced May 30, 2026