3.8 CS Flexible Cortex Drill Assembly 6100-00

GUDID 81195401072086

INTERVENTIONAL SPINE, INC

Cannulated surgical drill bit, reusable
Primary Device ID81195401072086
NIH Device Record Key011fb1b7-7b7f-437a-9b2f-a9e8b6bcd668
Commercial Distribution Discontinuation2016-12-23
Commercial Distribution StatusNot in Commercial Distribution
Brand Name3.8 CS Flexible Cortex Drill Assembly
Version Model Number6100-00
Catalog Number6100-00
Company DUNS017663522
Company NameINTERVENTIONAL SPINE, INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 497-0484
Emailcs@i-spineinc.com
Phone(800) 497-0484
Emailcs@i-spineinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS181195401072086 [Primary]

FDA Product Code

HTWBit, Drill

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[81195401072086]

Moist Heat or Steam Sterilization


[81195401072086]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-22
Device Publish Date2015-09-18

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