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 08800089416585 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416592 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416608 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416615 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416622 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416639 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416646 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416653 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416660 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416677 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 08800089416684 INLET System Bone Screw Jeil Medical Corporation LXT 2021-11-18 10381780065197 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065203 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065210 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065227 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065234 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065241 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065258 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065265 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065272 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065289 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065296 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065302 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065319 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065326 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065333 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065340 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065357 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065364 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09 10381780065371 Integra® Total Wrist Fusion System Ascension Orthopedics, Inc. LXT 2017-10-09
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