Octane P

GUDID 00840996154437

OCTANE P,PADDLE DISTRACTOR,15

Choice Spine, LP

Polymeric spinal interbody fusion cage

• Primary Device ID: 00840996154437
• NIH Device Record Key: ae38d017-3798-44b1-a768-6e1cf87aa405
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Octane P
• Version Model Number: 601-9115
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996154437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082270

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

[00840996154437]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-04
• Device Publish Date: 2024-02-24

On-Brand Devices [Octane P]

• 00840996154505: OCTANE P,TRIAL,17
• 00840996154499: OCTANE P,TRIAL,15
• 00840996154482: OCTANE P,TRIAL,13
• 00840996154475: OCTANE P,TRIAL,11
• 00840996154468: OCTANE P,TRIAL,9
• 00840996154451: OCTANE P,TRIAL,7
• 00840996154444: OCTANE P,PADDLE DISTRACTOR,17
• 00840996154437: OCTANE P,PADDLE DISTRACTOR,15
• 00840996154420: OCTANE P,PADDLE DISTRACTOR,13
• 00840996154413: OCTANE P,PADDLE DISTRACTOR,11
• 00840996154406: OCTANE P,PADDLE DISTRACTOR,9
• 00840996154390: OCTANE P,PADDLE DISTRACTOR,7
• 00840996154383: OCTANE P,GRAFT BLOCK