Na A06081S
Ref A06 081 SModel Z-Guide Wire
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 | Number4057217Z-GUIDEWIRESAP 04057217001050 | Date29 Oct 2021 | StatusActive |
| United States | GUDID listing GUDID | Number04057217001050 | Date10 Jun 2015 | 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- Withdrawn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
- Trade Name
- Z-Guide Wire
- Generic Name
- Pedicle screw guide
- Model / Reference
- Z-Guide Wire EUDAMEDA06 081 S EUDAMEDA06081S GUDID
- Primary DI / UDI-DI
- 04057217001050
- Basic UDI-DI
- 4057217Z-GUIDEWIRESAP
- FDA Product Code
- HTY
- EMDN Code
- V9012 Non-specialist surgical instruments and kits, single-use
- GMDN Term
- Pedicle screw guide
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 888.3040
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Z-Guide Wire A06 081 S | A06081S |
| Device Class | Class IIa | Class II |
Other devices from Z-Medical GmbH + Co. KG
Properties
Other properties (19)
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No