Home GUDID 00857915007606
PARA CPX
Primary DI 00857915007606
Brand PARA CPX
Company A.M. SURGICAL, INC.
Model 8800-10
Catalog number N/A
Device description PARA Cross Pin External Fixation Frame and One Tightening Tool
Published 2021-01-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 00857915007606 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 00857915007606 00857915007606 857915007606 0857915007606
GMDN Terms# Term, Definition table Term Definition External orthopaedic fixation system, single-use, sterile An assembly of sterile devices designed to stabilize fractured bones of the lower limbs to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur and tibia, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device.
Regulatory Flags# DUNS number 160020087 Device count 1 Kit true Lot or batch true Expiration date on label 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