Home GUDID M73910290070
TransFasten-LSF, Tissue Dilator
Primary DI M73910290070
Brand TransFasten-LSF, Tissue Dilator
Company CAPTIVA SPINE, INC.
Model 10-2-9007
Device description Tissue Dilator
Published 2024-04-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M73910290070 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Endoscopic-access dilator, single-use A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. 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#