Home GUDID 08800039825481
Faset
Primary DI 08800039825481
Brand Faset
Company DIOMEDICAL CO.,LTD.
Model A
Catalog number FA.IC.8001
Device description Ratcheting I-Handle, Cannulated
Published 2019-02-08
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Single use true
Product Codes# Code, Name table Code Name MRW SYSTEM, FACET SCREW SPINAL DEVICE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MRW System, Facet Screw Spinal Device Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08800039825481 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800039825481 08800039825481 8800039825481
GMDN Terms# Term, Definition table Term Definition Surgical instrument handle, non-torque-limiting A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 557795909 Device count 1 DM exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810131882761 Facet Sterile Implant - 55 Surgentec, LLC MRW 2026-07-06 00810131882808 Facet Sterile Instrument Kit - Cervical Surgentec, LLC MRW 2026-07-06 00810131884772 ION-C Final Kit Surgentec, LLC MRW 2026-07-06 00810131884895 ION-C Reusable Surgentec, LLC MRW 2026-07-06 08800039819909 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039819916 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039819923 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039819930 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039819947 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039819954 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039819961 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039819978 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039819985 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039819992 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039820004 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039820011 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039820028 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039820035 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039820042 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039820059 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039820318 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039820325 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039820332 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039820349 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039821391 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039823739 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039823746 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039823753 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039823760 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08 08800039823777 Faset DIOMEDICAL CO.,LTD. MRW 2019-02-08