Home GUDID 81195401244100 Access Needle
Primary DI 81195401244100
Brand Access Needle
Company INTERVENTIONAL SPINE, INC
Model 6949
Catalog number 6949
Device description PERPOS PLS System, Access Needle
Published 2015-09-21
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true 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 81195401244100 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 81195401244100 81195401244100
GMDN Terms# Term, Definition table Term Definition Bone access cannula A sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 017663522 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 00011954013448 8 Degree Lordotic, Opticage Expandable Interbody Implant 9101-21 9101-21 2016-05-25 81195401082986 Opticage Expandable Interbody Implant 9080-00 9080-00 2015-09-14 81195401107962 Opticage Expandable Interbody Implant 9080-01 9080-01 2015-09-14 81195401108648 Opticage Expandable Interbody Implant 9080-02 9080-02 2015-09-14 81195401109393 Opticage Expandable Interbody Implant 9080-03 9080-03 2015-09-14 81195401110900 Opticage Expandable Interbody Implant 9080-04 9080-04 2015-09-14 81195401111686 Opticage Expandable Interbody Implant 9080-05 9080-05 2015-09-14 81195401112362 Opticage Expandable Interbody Implant 9080-06 9080-06 2015-09-14 81195401113048 Opticage Expandable Interbody Implant 9080-07 9080-07 2015-09-14 81195401114724 Opticage Expandable Interbody Implant 9080-08 9080-08 2015-09-14 81195401115400 Opticage Expandable Interbody Implant 9080-09 9080-09 2015-09-14 81195401116186 Opticage Expandable Interbody Implant 9080-10 9080-10 2015-09-14 81195401117862 Opticage Expandable Interbody Implant 9080-11 9080-11 2015-09-14 81195401245886 Opticage Expandable Interbody Implant 9080-12 9080-12 2015-09-23 81195401246562 Opticage Expandable Interbody Implant 9080-13 9080-13 2015-09-23 81195401247248 Opticage Expandable Interbody Implant 9080-14 9080-14 2015-09-23 81195401248924 Opticage Expandable Interbody Implant 9080-15 9080-15 2015-09-23 81195401249600 Opticage Expandable Interbody Implant 9080-16 9080-16 2015-09-23 81195401250286 Opticage Expandable Interbody Implant 9080-17 9080-17 2015-09-23 81195401251962 Opticage Expandable Interbody Implant 9080-18 9080-18 2015-09-23
Other Devices Sharing Product Codes# 
i-spineinc.com