VERSALOOP™ 25° Guide for 1.5mm Anchor, Sawtooth
by T.A.G. Medical products corporation LTD. Israel EUDAMEDGUDID
Ref 514375mModel Versaloop System-Reusable Instruments
Product code LXHEMDN L0299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number81012846VERSALOOPOREBH | Date22 Dec 2024 | StatusActive |
| United States | GUDID listing GUDID | Number10818674024959 | Date3 Dec 2020 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Generic Name
- Orthopaedic guidewire, reusable
- Device Name
- VERSALOOP™ Straight Guide for 1.5mm Anchor, Fishmouth
- Model / Ref / Catalog
- Versaloop System-Reusable Instruments, 514375m, 210197
- Primary DI / UDI-DI
- 10818674024959
- Basic UDI-DI
- 81012846VERSALOOPOREBH
- Direct Marketing DI
- 10818674024959
- FDA Product Code
- LXH
- EMDN Code
- L0299 Suture instruments, reusable - other
- GMDN Term
- Orthopaedic guidewire, reusable
- 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 | Versaloop System-Reusable Instruments 514375m | 210197 |
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 (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
Sources (2)
- EUDAMED 7249f1f6-19c5-4256-a8ba-fa321fa37e6d
- FDA UDI 49972185-8b71-49e7-a996-a92fc19f57f2