TransFasten - LSF, Open-Ended Offset Guide

GUDID M73910290170

Open-Ended Offset Guide

CAPTIVA SPINE, INC.

Surgical drill guide, reusable

• Primary Device ID: M73910290170
• NIH Device Record Key: d7dbe478-9725-4dfe-a1c6-1a3dc4a096b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TransFasten - LSF, Open-Ended Offset Guide
• Version Model Number: 10-2-9017
• Company DUNS: 836975784
• Company Name: CAPTIVA SPINE, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M73910290170 [Primary]

FDA Product Code

• HXY: Brace, Drill

Sterilization

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

[M73910290170]

Moist Heat or Steam Sterilization

[M73910290170]

Moist Heat or Steam Sterilization

[M73910290170]

Moist Heat or Steam Sterilization

[M73910290170]

Moist Heat or Steam Sterilization

[M73910290170]

Moist Heat or Steam Sterilization

[M73910290170]

Moist Heat or Steam Sterilization

[M73910290170]

Moist Heat or Steam Sterilization

[M73910290170]

Moist Heat or Steam Sterilization

[M73910290170]

Moist Heat or Steam Sterilization

[M73910290170]

Moist Heat or Steam Sterilization

[M73910290170]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-03
• Device Publish Date: 2024-04-25

Devices Manufactured by CAPTIVA SPINE, INC.

• M739161554030 - MIS Curved Rod, Ø5.5 x 30mm: 2025-05-28 MIS Curved Rod
• M739161554035 - MIS Curved Rod, Ø5.5 x 35mm: 2025-05-28 MIS Curved Rod
• M739161554040 - MIS Curved Rod, Ø5.5 x 40mm: 2025-05-28 MIS Curved Rod
• M739161554045 - MIS Curved Rod, Ø5.5 x 45mm: 2025-05-28 MIS Curved Rod
• M739161554050 - MIS Curved Rod, Ø5.5 x 50mm: 2025-05-28 MIS Curved Rod
• M739161554055 - MIS Curved Rod, Ø5.5 x 55mm: 2025-05-28 MIS Curved Rod
• M739161554060 - MIS Curved Rod, Ø5.5 x 60mm: 2025-05-28 MIS Curved Rod
• M739161554065 - MIS Curved Rod, Ø5.5 x 65mm: 2025-05-28 MIS Curved Rod