Home GUDID 00845694031189 OsteoMed
Primary DI 00845694031189
Brand OsteoMed
Company OSTEOMED LLC
Model 800-1130
Catalog number 800-1130
Device description PrimaLOK FF 30mm Implant Assembly
Published 2015-05-22
Public version status Update
Distribution status Not 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 00845694031189 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00845694031189 00845694031189 845694031189 0845694031189
GMDN Terms# Term, Definition table Term Definition Orthopaedic fixation plate kit, non-bioabsorbable, non-sterile A non-sterile collection of small sheets of firm material and bone screws intended to be implanted onto fractured bone fragments to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the component material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.
Device Sizes# Type, Value, Unit table Type Value Unit Length 30 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 606417780 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
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