Cervical Trial 4 x 16 mm 8° short
by NGMedical GmbH EUDAMEDGUDID 2 variants
Active
Ref I099, I067
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number04251631419044 | Date20 Jan 2026 | StatusListed |
| European Union | CE/MDR EUDAMED | Number42516314TD020IIa4W | Date23 Oct 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Recalls
No FDA recalls on record, checked 23 Oct 2026.
Specification
- Trade Name
- Cervical Trial 4 x 16 mm 8° short EUDAMEDCervical Trial 4 x 16 mm 8° EUDAMEDBee GUDID
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device Name
- Cervical Trial
- Model / Ref / Catalog
- I099, I067, Cervical Trial 4 x 16 mm 8° short, Cervical Trial 4 x 16 mm 8°
- Primary DI / UDI-DI
- 04251631419044, 04251631418726, 04251631416807, 04251631417347, 04251631416487, 04251631417026
- Basic UDI-DI
- 42516314TD020IIa4W
- Direct Marketing DI
- 042516314190440425163141872604251631416807042516314173470425163141648704251631417026
- 510(k) Number
- FDA Product Code
- LXH
- EMDN Code
- L1199 Neurosurgery instruments, reusable - other
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 888.4540
- Market of Registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | I099 I067 | Cervical Trial 4 x 16 mm 8° short Cervical Trial 4 x 16 mm 8° |
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- DE-MF-000000204
Other devices from NGMedical GmbH
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Lot / Batch Number: No
- Expiration Date: No