TOMCAT Cervical Spinal System

GUDID 00840996158725

TOMCAT,STERILE,ZEROP,HA,16X14X8,9

Choice Spine, LP

Intervertebral-body internal spinal fixation system
Primary Device ID00840996158725
NIH Device Record Keyfead70da-ba47-4dfa-8c0c-69786e9eaf47
Commercial Distribution StatusIn Commercial Distribution
Brand NameTOMCAT Cervical Spinal System
Version Model NumberS-RH20-1614809
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
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+1(865)246-3333
Emailinfo@choicespine.net

Device Dimensions

Height9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996158725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OVEIntervertebral fusion device with integrated fixation, cervical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-06-28

On-Brand Devices [TOMCAT Cervical Spinal System]

00840996176385Tomcat, Driver, Angled, U-Joint
00840996175692TOMCAT,DRILL GUIDE,OFFSET
00840996175685TOMCAT,OP GUIDE,PLUGS,12 HEIGHT
00840996175678TOMCAT,OP GUIDE,PLUGS,11 HEIGHT
00840996175661TOMCAT,OP GUIDE,PLUGS,10 HEIGHT
00840996175654TOMCAT,OP GUIDE,PLUGS,9 HEIGHT
00840996175647TOMCAT,OP GUIDE,PLUGS,8 HEIGHT
00840996175630TOMCAT,OP GUIDE,PLUGS,7 HEIGHT
00840996175623TOMCAT,OP GUIDE,PLUGS,6 HEIGHT
00840996173919TOMCAT,AWL,SPRING LOADED
00840996163897TOMCAT,FIXED ANGLE DRILL, 14D
00840996163880TOMCAT,FIXED ANGLE DRILL, 12D
00840996163873TOMCAT,0P GUIDE,PLUG, 12 HEIGHT
00840996163866TOMCAT,0P GUIDE,PLUG, 11 HEIGHT
00840996163859TOMCAT,0P GUIDE,PLUG, 10 HEIGHT
00840996163842TOMCAT,0P GUIDE,PLUG, 9 HEIGHT
00840996163835TOMCAT,0P GUIDE,PLUG, 8 HEIGHT
00840996163828TOMCAT,0P GUIDE,PLUG, 7 HEIGHT
00840996163811TOMCAT,0P GUIDE,PLUG, 6 HEIGHT
00840996163705TOMCAT,THREADED SCREWDRIVER
00840996161428TOMCAT,DRIVER,ANGLED,SHORT
00840996150330TOMCAT,AWL,ANGLED,LONG
00840996150149TOMCAT,U-JOINT,FORCEPS
00840996150132TOMCAT,U-JOINT DRIVER,SPLIT TIP W/COLLAR
00840996160292TOMCAT,STERILE,HYBRID,HA,16X18X8,12
00840996160285TOMCAT,STERILE,HYBRID,HA,16X18X8,11
00840996160278TOMCAT,STERILE,HYBRID,HA,16X18X8,10
00840996160261TOMCAT,STERILE,HYBRID,HA,16X18X8,9
00840996160254TOMCAT,STERILE,HYBRID,HA,16X18X8,8
00840996160247TOMCAT,STERILE,HYBRID,HA,16X18X8,7
00840996160230TOMCAT,STERILE,HYBRID,HA,16X18X8,6
00840996160223TOMCAT,STERILE,HYBRID,HA,16X16X8,12
00840996160216TOMCAT,STERILE,HYBRID,HA,16X16X8,11
00840996160209TOMCAT,STERILE,HYBRID,HA,16X16X8,10
00840996160193TOMCAT,STERILE,HYBRID,HA,16X16X8,9
00840996160186TOMCAT,STERILE,HYBRID,HA,16X16X8,8
00840996160179TOMCAT,STERILE,HYBRID,HA,16X16X8,7
00840996160162TOMCAT,STERILE,HYBRID,HA,16X16X8,6
00840996160155TOMCAT,STERILE,HYBRID,HA,16X14X8,12
00840996160148TOMCAT,STERILE,HYBRID,HA,16X14X8,11
00840996160131TOMCAT,STERILE,HYBRID,HA,16X14X8,10
00840996160124TOMCAT,STERILE,HYBRID,HA,16X14X8,9
00840996160117TOMCAT,STERILE,HYBRID,HA,16X14X8,8
00840996160100TOMCAT,STERILE,HYBRID,HA,16X14X8,7
00840996160094TOMCAT,STERILE,HYBRID,HA,16X14X8,6
00840996160087TOMCAT,STERILE,HYBRID,HA,14X12X8,12
00840996160070TOMCAT,STERILE,HYBRID,HA,14X12X8,11
00840996160063TOMCAT,STERILE,HYBRID,HA,14X12X8,10
00840996160056TOMCAT,STERILE,HYBRID,HA,14X12X8,9
00840996160049TOMCAT,STERILE,HYBRID,HA,14X12X8,8

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