HARRIER-SA

GUDID 00840996186285

HARRIER-SA,INSERTER,OLIF

Choice Spine, LP

Intervertebral-body internal spinal fixation system

• Primary Device ID: 00840996186285
• NIH Device Record Key: bdd0e916-a57d-42dc-82be-6ab4d7d033d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HARRIER-SA
• Version Model Number: Y070-0058
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840996186285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180519

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

[00840996186285]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [HARRIER-SA]

• 00840996187299: HARRIER-SA,INSERTER,TRIAL,OFF ANGLE
• 00840996186285: HARRIER-SA,INSERTER,OLIF
• 00840996186230: HARRIER-SA,TRIAL,INSERTER,FIXED