Home GUDID 00193982118334 ANTHEM
Primary DI 00193982118334
Brand ANTHEM
Company GLOBUS MEDICAL, INC.
Model 1170.1134
Device description ANTHEM Anterolateral Distal Tibia Plate, 3.5mm Polyaxial, Left, 14 hole, 235mm, Ti
Published 2021-01-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 00193982118334 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 00193982118334 00193982118334 193982118334 0193982118334
GMDN Terms# Term, Definition table Term Definition Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 139105691 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