Octane T

GUDID 00840996155557

OCTANE,KERRISON BAY,2MM

Choice Spine, LP

Polymeric spinal interbody fusion cage
Primary Device ID00840996155557
NIH Device Record Key2596c99b-be24-4e46-bcfa-88f5c10d99b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameOctane T
Version Model Number600-9022
Company DUNS078293017
Company NameChoice Spine, LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100840996155557 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

[00840996155557]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-04
Device Publish Date2024-02-24

On-Brand Devices [Octane T]

00840996169172OCTANE T,NON-STRL 17MM
00840996169165OCTANE T,NON-STRL 15MM
00840996169158OCTANE T,NON-STRL 13MM
00840996169141OCTANE T,NON-STRL 11MM
00840996169134OCTANE T,NON-STRL 9MM
00840996169127OCTANE T,NON-STRL 7MM
00840996160698OCTANE T,INSERTER, THREADED,SM
00840996155700OCTANE,SM AXL Z-CONN HANDLE
00840996155694OCTANE,LAMINA SPREADER
00840996155687OCTANE,CUP CURETTE SM ANGLE
00840996155670OCTANE,CUP CURETTE SM STRAIGHT
00840996155663OCTANE,CUP CURETTE UP ANGLE
00840996155656OCTANE,CUP CURETTE STRAIGHT
00840996155649OCTANE,RING CURETTE LEFT ANGLE
00840996155632OCTANE,RING CURETTE RIGHT ANGLE
00840996155625OCTANE,STR RING CURETTE
00840996155618OCTANE,UP RONGEUR,5MM
00840996155601OCTANE,UP RONGEUR,3MM
00840996155595OCTANE,STR RONGEUR,5MM
00840996155588OCTANE,STR RONGEUR,3MM
00840996155571OCTANE,KERRISON BAY,4MM
00840996155564OCTANE,KERRISON BAY,3MM
00840996155557OCTANE,KERRISON BAY,2MM
00840996155540OCTANE,OSTEOTOME,9MM
00840996155533OCTANE,OSTEOTOME,6MM
00840996155526OCTANE,NERVE RETRACTOR,8MM BAY
00840996155519OCTANE,NERVE RETRACTOR,8MM 90DEG
00840996155502OCTANE,NERVE RETRACTOR,5MM BAY
00840996155496OCTANE,NERVE RETRACTOR,5MM 90DEG
00840996154376OCTANE T,BOX CHISEL,17
00840996154369OCTANE T,BOX CHISEL,15
00840996154352OCTANE T,BOX CHISEL,13
00840996154345OCTANE T,BOX CHISEL,11
00840996154338OCTANE T,BOX CHISEL,9
00840996154321OCTANE T,BOX CHISEL,7
00840996154314OCTANE,SM AXIAL HANDLE Z CN
00840996154307OCTANE T,TRIAL,17
00840996154291OCTANE T,TRIAL,15
00840996154284OCTANE T,TRIAL,13
00840996154277OCTANE T,TRIAL,11
00840996154260OCTANE T,TRIAL,9
00840996154253OCTANE T,TRIAL,7
00840996154246OCTANE T,RASP,ANGLED
00840996154239OCTANE T,RASP,STRAIGHT
00840996154222OCTANE T,PUSHER,ANGLED
00840996154215OCTANE T,PUSHER
00840996154208OCTANE T,IMPACTION TOOL,ANGLED
00840996154192OCTANE T,IMPACTION TOOL,STRAIGHT
00840996154185OCTANE T,THRD IMPLANT INSERTER
00840996154178OCTANE T,INSERTER,ARTICULATED
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