Home GUDID 00840916160135 SPARTAN
Primary DI 00840916160135
Brand SPARTAN
Company SPINAL ELEMENTS
Model 10313
Device description SPARTAN SCREW SHIRT WASHER
Published 2020-12-07
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
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 00840916160135 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 00840916160135 00840916160135 840916160135 0840916160135
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system rod An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 004022104 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00810131885045 ION Non Cervical Surgentec, LLC MRW 2026-07-28 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 00810131881795 ION Disposable Instrument Kit Surgentec, LLC MRW 2026-03-09 00810131881801 ION 55 Facet Implant - Sterile Surgentec, LLC MRW 2026-03-09 00810131881818 ION 60 Facet Implant - Sterile Surgentec, LLC MRW 2026-03-09 00810131881825 ION 65 Facet Implant - Sterile Surgentec, LLC MRW 2026-03-09 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