Guidewire, Nitinol, Non-Threaded

GUDID M739985147508

CAPTIVA SPINE, INC.

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• Primary Device ID: M739985147508
• NIH Device Record Key: 732fa2ca-6670-4419-b349-6aed96db0353
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guidewire, Nitinol, Non-Threaded
• Version Model Number: 98514-7508
• 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
• Phone: 561-277-9480
• Email: info@captivaspine.com
• Phone: 561-277-9480
• Email: info@captivaspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M739985147508 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

[M739985147508]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-18
• Device Publish Date: 2022-07-24

Devices Manufactured by CAPTIVA SPINE, INC.

• M739203000210 - 4-Hole Drill Guide: 2024-03-19 4-Hole LD Drill Guide
• M739985221229 - TransFasten: 2024-03-19 LD (.125” Wire) Marking Pin, 229mm, Non-Threaded Trocar
• M739985221305 - TransFasten: 2024-03-19 LD (.125” Wire) Marking Pin, 305mm, Non-Threaded Trocar
• M739985222229 - TransFasten: 2024-03-19 LD (.125” Wire) Marking Pin, 229mm, Conical Blunt
• M73910110250 - TransFasten - LSF (Lateral Sacroiliac Fusion System): 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 25mm (L)
• M73910110300 - TransFasten - LSF (Lateral Sacroiliac Fusion System): 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 30mm (L)
• M73910110350 - TransFasten - LSF (Lateral Sacroiliac Fusion System): 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 35mm (L)
• M73910110400 - TransFasten - LSF (Lateral Sacroiliac Fusion System): 2024-03-11 Sacroiliac Immobilization Device - 9mm (D) x 40mm (L)