Home GUDID H67903390052S0 NA
Primary DI H67903390052S0
Brand NA
Company Synthes GmbH
Model 03.390.052S
Catalog number 03390052S
Device description DISTAL RADIUS FIXATOR KIT 200MM ROD/SCHANZ SCREW-STERILE
Published 2015-09-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name LXT APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10886982079541 Primary GS1 0 H67903390052S0 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10886982079541 10886982079541
GMDN Terms# Term, Definition table Term Definition Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial A collection of small sheets of firm material and bone screws intended to be implanted onto fractured bone fragments to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. The components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre); it does not include an antimicrobial agent(s). Tools for implantation may be included. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 486711679 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true 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 00885556819791 UNI-CP Compression Plate Smith & Nephew, Inc. LXT 2023-10-26 00885556839942 Total Wrist Fusion System Smith & Nephew, Inc. LXT 2022-12-21 00885556839959 Total Wrist Fusion System Smith & Nephew, Inc. LXT 2022-12-21 00885556839966 Total Wrist Fusion System Smith & Nephew, Inc. LXT 2022-12-21 00887868549236 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549243 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549250 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549267 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549274 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549281 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549298 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549304 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549311 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549328 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549335 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549342 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549359 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549366 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549373 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868549380 MULTI-DIRECTIONAL SCREW Biomet Orthopedics, LLC LXT 2022-11-14 00887868544699 SMOOTH PEG Biomet Orthopedics, LLC LXT 2022-09-07 00887868544705 SMOOTH PEG Biomet Orthopedics, LLC LXT 2022-09-07 00887868544712 SMOOTH PEG Biomet Orthopedics, LLC LXT 2022-09-07 00887868544729 SMOOTH PEG Biomet Orthopedics, LLC LXT 2022-09-07 00887868544736 SMOOTH PEG Biomet Orthopedics, LLC LXT 2022-09-07 00887868544743 SMOOTH PEG Biomet Orthopedics, LLC LXT 2022-09-07 00887868544750 SMOOTH PEG Biomet Orthopedics, LLC LXT 2022-09-07 00887868544767 SMOOTH PEG Biomet Orthopedics, LLC LXT 2022-09-07 00887868544774 SMOOTH PEG Biomet Orthopedics, LLC LXT 2022-09-07 00887868544781 SMOOTH PEG Biomet Orthopedics, LLC LXT 2022-09-07