Columbus Revision F
Ref NQ604, NP090M, NQ606, NQ600, NQ603, NQ622R, NP088M, NP105, NP097M, NP062M, NP051M
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number403923900000256634 | Date10 Dec 2025 | StatusActive |
| United States | GUDID listing GUDID | Number04046963398774 | Date8 May 2020 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, reusableSurgical instrument/implant rack
- Device Name
- COLUMBUS instrument setCOLUMBUS implantation instrument IIaCOLUMBUS instrument tray
- Model / Ref / Catalog
- NQ604, NP090M, NQ606, NQ600, NQ603, NP097M, NP062M, NP051M, NP088M, NP105, NQ622R
- Primary DI / UDI-DI
- 04046963398774, 04046963850111, 04046963398798, 04046963398736, 04046963398767, 04046963850159, 04046963849979, 04046963849924, 04046963850104, 04046963851033, 04046963402914
- Basic UDI-DI
- 403923900000256634, 40392390000016422L, 4039239000000330ZL
- Direct Marketing DI
- 04046963402914
- FDA Product Code
- HWT, FSM
- EMDN Code
- L091199, S010401
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, reusableSurgical instrument/implant rack
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDGUDID
- Regulation Number
- 888.4800, 878.4800
- EU market of registration
- Germany
- GUDID distribution status
- Not in Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa Class I | Class I |
Manufacturer details
- EUDAMED SRN
- DE-MF-000005504
Other devices from Aesculap AG
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: 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
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No