Octane Straight

GUDID 00840996177368

Octane Straight Trail 24mmX10mmX14mm

Choice Spine, LP

Intervertebral-body internal spinal fixation system

• Primary Device ID: 00840996177368
• NIH Device Record Key: 026288c2-92da-4c1f-a922-283417db3cbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Octane Straight
• Version Model Number: 05-049-20-0014
• Company DUNS: 078293017
• Company Name: Choice Spine, LP
• Device Count: 1
• DM Exempt: true
• 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.com
• Phone: +1(865)246-3333
• Email: info@choicespine.com
• Phone: +1(865)246-3333
• Email: info@choicespine.com
• Phone: +1(865)246-3333
• Email: info@choicespine.com
• Phone: +1(865)246-3333
• Email: info@choicespine.com
• Phone: +1(865)246-3333
• Email: info@choicespine.com
• Phone: +1(865)246-3333
• Email: info@choicespine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996177368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150152

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840996177368]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-28
• Device Publish Date: 2019-06-20

On-Brand Devices [Octane Straight]

• 00840996177375: Octane Straight Trail 24mmX10mmX15mm
• 00840996177368: Octane Straight Trail 24mmX10mmX14mm
• 00840996177351: Octane Straight Trail 24mmX10mmX13mm
• 00840996177344: Octane Straight Trail 24mmX10mmX12mm
• 00840996177337: Octane Straight Trail 24mmX10mmX11mm
• 00840996177320: Octane Straight Trail 24mmX10mmX10mm
• 00840996177313: Octane Straight Trail 24mmX10mmX9mm
• 00840996177306: Octane Straight Trail 24mmX10mmX8mm
• 00840996177290: Octane Straight Trail 24mmX10mmX7mm
• 00840996177283: Octane Straight Trail 24mmX10mmX6mm
• 00840996153669: OCTANE STR,NON THREAD OFF INSERTER
• 00840996150309: OCTANE STR,THREADED INSERTER BODY OFFSET
• 00840996155762: OCTANE M,RAIL REMOVAL TOOL
• 00840996155755: OCTANE,RASP ANGLED
• 00840996155748: OCTANE,RASP STRAIGHT
• 00840996155731: OCTANE,GRAFT TAMP
• 00840996155724: OCTANE,BOX CHISEL
• 00840996155717: OCTANE,SOLID IMPLANT INSERTER
• 00840996153652: OCTANE STR,THREADED INSERTER BODY OFFSE
• 00840996153645: OCTANE STR,NON THREAD INSERTER
• 00840996153638: OCTANE STR,SLAP HAMMER
• 00840996153621: OCTANE STRAIGHT,IMPLANT PUSHER,ANGLED
• 00840996153614: OCTANE STRAIGHT,IMPLANT PUSHER