Home GUDID 00190837119034 Simpact
Primary DI 00190837119034
Brand Simpact
Company Life Spine, Inc.
Model 152-14-940
Published 2021-10-04
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 HWC Screw, Fixation, Bone OUR Sacroiliac Joint Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWC Screw, Fixation, Bone Orthopedic 2 OUR Sacroiliac Joint Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190837119034 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 00190837119034 00190837119034 190837119034 0190837119034
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 183641617 Device count 1 Lot or batch 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 M179GSI265STS0 Sacroiliac Joint Fusion Genesys Orthopedics Systems LLC OUR 2026-07-14 M719G120140 SIros-X Genesys Orthopedics Systems LLC OUR 2026-07-14 M719GGSI265XLGS0 Sacroiliac Joint Fusion Genesys Orthopedics Systems LLC OUR 2026-07-14 05055662970890 ORTHO SOLUTIONS SUCCESSION AFN SYSTEM ORTHO SOLUTIONS HOLDINGS LIMITED HWC 2026-07-10 05055662971514 ORTHO SOLUTIONS SUCCESSION AFN SYSTEM ORTHO SOLUTIONS HOLDINGS LIMITED HWC 2026-07-10 00885556904879 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556904923 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906163 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906170 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906187 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906194 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906200 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906217 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906224 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906231 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906248 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906255 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906262 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906279 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906286 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906293 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906309 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906316 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556906323 EVOS Smith & Nephew, Inc. HWC 2026-06-25 00885556901946 EVOS Smith & Nephew, Inc. HWC 2026-06-24 00888867460973 Arthrex® ARTHREX, INC. HWC 2026-06-11 00193982586393 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10 00193982586416 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10 00193982586430 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10 00193982586454 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10