Harrier,SA

GUDID 00840996192514

MEDTORQUE,HDL,AXIAL,TORQ,CCW,18IN-LLBS

Choice Spine, LP

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 00840996192514
• NIH Device Record Key: 667ad6cd-9e87-483b-8e47-af48275439b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harrier,SA
• Version Model Number: 2TS4-10-C06
• 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	00840996192514 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191367

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

Moist Heat or Steam Sterilization

[00840996192514]

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]

• 00840996192569: MEDTORQUE,HDL,AXIAL,TORQ,CCW,18IN-LBS
• 00840996192514: MEDTORQUE,HDL,AXIAL,TORQ,CCW,18IN-LLBS