Octane T

GUDID 00840996160698

OCTANE T,INSERTER, THREADED,SM

Choice Spine, LP

Polymeric spinal fusion cage, sterile

• Primary Device ID: 00840996160698
• NIH Device Record Key: 648aa0b7-6405-4bd7-bada-2bab43a19636
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Octane T
• Version Model Number: 600-9164
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net
• Phone: +1(865)246-3333
• Email: info@choicespine.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996160698 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070218

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

[00840996160698]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-07-21

On-Brand Devices [Octane T]

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