Multiple Procedure Torque-Limiting Handle 6219-00

GUDID 00811954013226

INTERVENTIONAL SPINE, INC

Surgical instrument handle, non-torque-limiting
Primary Device ID00811954013226
NIH Device Record Keyebd64665-18b3-4747-b3b9-b61215890ecc
Commercial Distribution Discontinuation2016-12-23
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMultiple Procedure Torque-Limiting Handle
Version Model Number6219-00
Catalog Number6219-00
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 Datetrue
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
GS100811954013226 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811954013226]

Moist Heat or Steam Sterilization


[00811954013226]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-09
Device Publish Date2016-03-16

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