Pre-Drill 6118

GUDID 81195401046100

INTERVENTIONAL SPINE, INC

Cannulated surgical drill bit, reusable
Primary Device ID81195401046100
NIH Device Record Key1754ba93-affe-4e12-980f-eff0e9a150a3
Commercial Distribution StatusIn Commercial Distribution
Brand NamePre-Drill
Version Model Number6118
Catalog Number6118
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
GS181195401046100 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[81195401046100]

Moist Heat or Steam Sterilization


[81195401046100]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-22
Device Publish Date2015-09-21

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81195401111686 - Opticage Expandable Interbody Implant2020-02-24 10mm Width x 30mm Length by 9mm-14mm Expandable Height
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