Home GUDID 08800039821735
Faset
Primary DI 08800039821735
Brand Faset
Company DIOMEDICAL CO.,LTD.
Model A
Catalog number FA.IN.4002
Device description DTS Dilator M
Published 2019-02-08
Public version status Update
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 08800039821735 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800039821735 08800039821735 8800039821735
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, reusable A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. 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