Home GUDID 08800037500212 Polarfix™ Facet Screw System
Primary DI 08800037500212
Brand Polarfix™ Facet Screw System
Company CG MedTech Co.,Ltd.
Model FSA5530N
Published 2018-08-21
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 08800037500212 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08800037500212 08800037500212 8800037500212
GMDN Terms# Term, Definition table Term Definition Surgical countersink, single-use A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a single-use device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 688811082 Device count 1 DM exempt true Lot or batch true Serial number 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