SwitchCut Reamer 4.5 x 6.0mm
by T.A.G. Medical products corporation LTD. Israel EUDAMEDGUDID
Ref 145060bsmModel SwitchCut Disposable Instruments Product code HTOEMDN P091301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number81012846SWITCHCUTINSEQ | Date23 Dec 2024 | StatusActive |
| United States | GUDID listing GUDID | Number10810190013653 | Date24 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- SwitchCut Reamer 4.5 x 6.0mm EUDAMEDSwitchcut Reamer 4.5x6.0mm GUDID
- Generic Name
- Cannulated surgical drill bit, single-use
- Model / Ref / Catalog
- SwitchCut Disposable Instruments EUDAMED145060bsm EUDAMEDC GUDID110026885 GUDID
- Primary DI / UDI-DI
- 10810190013653
- Basic UDI-DI
- 81012846SWITCHCUTINSEQ
- Direct Marketing DI
- 10810190013653
- FDA Product Code
- HTO
- EMDN Code
- P091301 Orthopaedic implant reamers, single-use
- GMDN Term
- Cannulated surgical drill bit, single-use
- Device Class
- Class IIa EUDAMEDClass I GUDID
- 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 | SwitchCut Disposable Instruments 145060bsm | C |
| Device Class | Class IIa | Class I |
Manufacturer details
- EUDAMED SRN
- IL-MF-000029151
- Authorised representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (2)
- EUDAMED 9c50c396-424d-40d0-acb1-08eb36d06147
- FDA UDI 09eb774f-9952-41bd-8054-447f3801def6