Home GUDID 08809595977818 Signex
Primary DI 08809595977818
Brand Signex
Company OSTEONIC CO.,Ltd.
Model A2B.08080
Published 2025-06-24
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 HRS Plate, Fixation, Bone HWC Screw, Fixation, Bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HRS Plate, Fixation, Bone Orthopedic 2 HWC Screw, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08809595977818 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08809595977818 08809595977818 8809595977818
GMDN Terms# Term, Definition table Term Definition Orthopaedic fixation plate, non-bioabsorbable A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 688999370 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 00885556836187 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836163 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836170 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836194 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836200 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836217 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836224 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836248 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836255 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836262 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556835999 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836002 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836019 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836026 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836033 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836040 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836057 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836064 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836071 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836088 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836095 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836118 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836125 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836132 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836149 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556836156 Ti6 Internal Fixation System Smith & Nephew, Inc. HWC 2022-12-22 00885556838785 Total Foot System 2 Smith & Nephew, Inc. HRS 2022-12-21 00885556838785 Total Foot System 2 Smith & Nephew, Inc. HWC 2022-12-21 00888867007475 Arthrex® ARTHREX, INC. HRS 2017-02-15 00888867007499 Arthrex® ARTHREX, INC. HRS 2017-02-15