Home GUDID H9804600280 NA
Primary DI H9804600280
Brand NA
Company SYNTHES (U.S.A.) LP
Model 460.028
Catalog number 460028
Device description LARGE TI STERNAL LOCKING H-PLATE/8 HOLES
Published 2015-09-14
Public version status Update
Distribution status 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 HWC Screw, fixation, bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWC Screw, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10887587055046 Primary GS1 0 H9804600280 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10887587055046 10887587055046
GMDN Terms# Term, Definition table Term Definition Sternal fixation device A collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 832637081 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 false 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 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 00193982586478 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10 00193982586690 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10 00193982586706 CAPTIVATE GLOBUS MEDICAL, INC. HWC 2026-06-10
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