Home GUDID H679394880 NA
Primary DI H679394880
Brand NA
Company Synthes GmbH
Model 394.88
Catalog number 39488
Device description LARGE EX-FIX 11MM CRBN FBR ROD 450MM / MR-CONDITIONAL
Published 2015-09-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Conditional
Rx true
OTC false
Sterile false
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 10886982199935 Primary GS1 0 H679394880 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10886982199935 10886982199935
GMDN Terms# Term, Definition table Term Definition External orthopaedic fixation system reprocessed component A component of an external fixation system intended to be used to stabilize a fractured bone/joint. It may be a specially designed frame, clamp, rod, pin, rod-to-rod coupling, rod-to-pin coupling, post, fastener, wire, bolt, washer, nut, hinge, ring, socket, bar, screw, or other device. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application.
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 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 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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