Betta Link LG Reusable Obturator
by T.A.G. Medical products corporation LTD. EUDAMEDGUDID
Active
Ref 184200bsmModel Betta Link™ Knotless Anchor System Reusable Instruments
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number10818674028896 | Date31 Mar 2025 | StatusIn distribution |
| European Union | CE/MDR EUDAMED | Number81012846BettaLinkREGW | Date29 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- Betta Link LG Reusable Obturator EUDAMEDBetta Link Long Reusable Obturator GUDID
- Generic Name
- Arthroscopic obturator
- Device Name
- Betta Link SR Reusable Pronged Guide
- Model / Ref / Catalog
- Betta Link™ Knotless Anchor System Reusable Instruments, 184200bsm, 110045219
- Primary DI / UDI-DI
- 10818674028896
- Basic UDI-DI
- 81012846BettaLinkREGW
- Direct Marketing DI
- 10818674028896
- FDA Product Code
- LXH
- EMDN Code
- L0299 Suture instruments, reusable - other
- GMDN Term
- Arthroscopic obturator
- Device Class
- Class I
- Regulation Number
- 888.4540
- Market of Registration
- Germany
- Commercial Distribution
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Betta Link™ Knotless Anchor System Reusable Instruments 184200bsm | 110045219 |
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
Show properties
Other properties (20)
- Sterile: No
- Single Use: No
- Implantable: 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
- Expiration Date: No