Small Quick Release Handle 6127-00

GUDID 81195401078262

INTERVENTIONAL SPINE, INC

Surgical instrument handle, non-torque-limiting
Primary Device ID81195401078262
NIH Device Record Keyf942eea7-e4ae-4401-93a2-5e14758b9e29
Commercial Distribution Discontinuation2016-12-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSmall Quick Release Handle
Version Model Number6127-00
Catalog Number6127-00
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
GS181195401078262 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[81195401078262]

Moist Heat or Steam Sterilization


[81195401078262]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-09
Device Publish Date2015-09-21

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81195401110900 - Opticage Expandable Interbody Implant2020-02-24 10mm Width x 26mm Length by 9mm-14mm Expandable Height
81195401111686 - Opticage Expandable Interbody Implant2020-02-24 10mm Width x 30mm Length by 9mm-14mm Expandable Height
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