Home GUDID M739985221229 TransFasten
Primary DI M739985221229
Brand TransFasten
Company CAPTIVA SPINE, INC.
Model 98522-1229
Device description LD (.125” Wire) Marking Pin, 229mm, Non-Threaded Trocar
Published 2024-03-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name FZX Guide, Surgical, Instrument KIL Positioner, Socket LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FZX Guide, Surgical, Instrument General, Plastic Surgery 1 KIL Positioner, Socket Orthopedic 1 LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M739985221229 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning instrument, single-use A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 836975784 Device count 1 Premarket exempt true Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M739131064012 Variable Screw, Self-Tapping, 4.0mm x 12mm 13106-4012 2015-10-30 M739131064014 Variable Screw, Self-Tapping, 4.0mm x 14mm 13106-4014 2015-10-30 M739131064016 Variable Screw, Self-Tapping, 4.0mm x 16mm 13106-4016 2015-10-30 M739131064018 Variable Screw, Self-Tapping, 4.0mm x 18mm 13106-4018 2015-10-30 M739131164012 Fixed Screw, Self-Tapping, 4.0mm x 12mm 13116-4012 2015-10-30 M739131164014 Fixed Screw, Self-Tapping, 4.0mm x 14mm 13116-4014 2015-10-30 M739131164016 Fixed Screw, Self-Tapping, 4.0mm x 16mm 13116-4016 2015-10-30 M739131164018 Fixed Screw, Self-Tapping, 4.0mm x 18mm 13116-4018 2015-10-30 M73924712832 Cross Connector, XSmall 2471-2832 2015-10-30 M73924713139 Cross Connector, Small 2471-3139 2015-10-30 M73924713752 Cross Connector, Medium 2471-3752 2015-10-30 M73924714963 Cross Connector, Medium-Large 2471-4963 2015-10-30 M73924714975 Cross Connector, Large 2471-4975 2015-10-30 M739CP30020 1-Level Cervical Plates, 20 mm CP30020 2015-10-30 M739CP300200 1-Level Cervical Plates, 20 mm CP30020 2017-08-11 M739CP30022 1-Level Cervical Plates, 22 mm CP30022 2015-08-28 M739CP300220 1-Level Cervical Plates, 22 mm CP30022 2017-08-11 M739CP30024 1-Level Cervical Plates, 24 mm CP30024 2015-08-28 M739CP300240 1-Level Cervical Plates, 24 mm CP30024 2017-08-11 M739CP30026 1-Level Cervical Plates, 26 mm CP30026 2015-08-28
Other Devices Sharing Product Codes# 
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