Cervical Inserter Impactor Cap
by NGMedical GmbH EUDAMEDGUDID
Active
Ref I024
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number42516314TD020Ir4C | Date23 Oct 2025 | StatusActive |
| United States | GUDID listing GUDID | Number04251631400820 | Date13 Jul 2022 | StatusListed |
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- Withdrawn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 22 Oct 2026.
Specification
- Trade Name
- Cervical Inserter Impactor Cap EUDAMEDBee GUDID
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device Name
- Cervical Instruments
- Model / Ref / Catalog
- I024, Cervical Inserter Impactor Cap
- Primary DI / UDI-DI
- 04251631400820
- Basic UDI-DI
- 42516314TD020Ir4C
- 510(k) Number
- FDA Product Code
- LXH
- EMDN Code
- L091099 Osteosynthesis instruments, reusable - other
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device Class
- Class I
- 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 | I024 | Cervical Inserter Impactor Cap |
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