Guided RP Ratchet Fixture Mount S-5.5, Screw Retained
by Adin Dental Implant Systems LTD.
Ref GS0037Model Tool
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 | Number729010930GuideSurgerTol8B 07290109302249 | Date13 Mar 2024 | StatusActive |
| United States | GUDID listing GUDID | Number07290109302249 | Date16 May 2021 | 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- Withdrawn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
- Dental torque wrench adaptor
- Model / Reference
- Tool, GS0037
- Primary DI / UDI-DI
- 07290109302249
- Basic UDI-DI
- 729010930GuideSurgerTol8B
- FDA Product Code
- NDP
- EMDN Code
- P01020180 Dental implants - accessories
- GMDN Term
- Dental torque wrench adaptor
- Device Class
- Class I
- Regulation Number
- 872.3980
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Manufacturer details
- EUDAMED SRN
- IL-MF-000014625
- Authorised representative
- MedNet EC-REP GmbH DE-AR-000000002
Other devices from Adin Dental Implant Systems Ltd.
Properties
Other properties (20)
- Sterile: No
- Single Use: No
- 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
- Serial Number: No
- Expiration Date: No