2.4 MM Short Disposable Drill Bit
by T.A.G. Medical products corporation LTD.
Ref 185100bsmModel Betta Link™ Knotless Anchor System
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 |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number10818674028919 | Date31 Mar 2025 | StatusListed |
| European Union | CE/MDR EUDAMED | Number81012846BettaLinkORTHW8 10818674028919 | Date29 Dec 2024 | StatusActive |
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- Withdrawn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
- Betta Link Disposable Hard Bone Drill Bit
- Model / Ref / Catalog
- Betta Link™ Knotless Anchor System, 185100bsm, 110045591
- Primary DI / UDI-DI
- 10818674028919
- Basic UDI-DI
- 81012846BettaLinkORTHW8
- Direct Marketing DI
- 10818674028919
- FDA Product Code
- HTW
- 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 | Betta Link™ Knotless Anchor System 185100bsm | 110045591 |
| 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.
See all devices from T.A.G. Medical products corporation LTD. →
Properties
Other properties (18)
- 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
- Serial Number: No