AMBASSADOR

GUDID 00840996182621

AMBASSADOR,BARREL FIXATION PIN

Choice Spine, LP

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00840996182621
• NIH Device Record Key: 7c3f59ca-da31-4e48-9d4a-35f22be7669e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMBASSADOR
• Version Model Number: 05-109-18-0026
• 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	00840996182621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143576

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

Moist Heat or Steam Sterilization

[00840996182621]

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