FlipCutter® III Drill
by T.A.G. Medical products corporation LTD.
Ref 144000arModel FlipCutter
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 | Number81012846FlipCutterC2 10818674021446 | Date17 Dec 2024 | StatusActive |
| United States | GUDID listing GUDID | Number10818674021446 | Date17 Jan 2024 | 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- Withdrawn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
- Cannulated surgical drill bit, single-use
- Device Name
- FlipCutter
- Model / Ref / Catalog
- FlipCutter, 144000ar, AR-1204FF
- Primary DI / UDI-DI
- 10818674021446
- Basic UDI-DI
- 81012846FlipCutterC2
- Direct Marketing DI
- 10818674021446
- FDA Product Code
- HTO
- EMDN Code
- Z12130503 Orthopaedic surgical drills
- GMDN Term
- Cannulated surgical drill bit, single-use
- Device Class
- Class IIa EUDAMEDClass I GUDID
- Regulation Number
- 888.4540
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | FlipCutter 144000ar | AR-1204FF |
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- IL-MF-000029151
- Authorised representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Other devices from T.A.G. Medical products corporation LTD.
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Properties
Other properties (17)
- 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
- Prescription Use: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No