Distraction Paddle - 8mm

GUDID 00850065741635

Distraction Paddle - 8mm

CAPTIVA SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00850065741635
• NIH Device Record Key: 022ea5da-b1d6-4ac0-a67f-e3f677563f20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distraction Paddle - 8mm
• Version Model Number: CSE06-R-1800-40
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850065741635 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00850065741635]

Moist Heat or Steam Sterilization

[00850065741635]

Moist Heat or Steam Sterilization

[00850065741635]

Moist Heat or Steam Sterilization

[00850065741635]

Moist Heat or Steam Sterilization

[00850065741635]

Moist Heat or Steam Sterilization

[00850065741635]

Moist Heat or Steam Sterilization

[00850065741635]

Moist Heat or Steam Sterilization

[00850065741635]

Moist Heat or Steam Sterilization

[00850065741635]

Moist Heat or Steam Sterilization

[00850065741635]

Moist Heat or Steam Sterilization

[00850065741635]

Moist Heat or Steam Sterilization

[00850065741635]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-27
• Device Publish Date: 2025-08-19

Devices Manufactured by CAPTIVA SPINE, INC.

• 00850065741567 - Trial 7mm: 2025-08-27 7mm Trial
• 00850065741574 - Trial 8mm: 2025-08-27 8mm Trial
• 00850065741581 - Trial 9mm: 2025-08-27 9mm Trial
• 00850065741598 - Trial 10mm: 2025-08-27 10mm Trial
• 00850065741604 - Trial 11mm: 2025-08-27 11mm Trial
• 00850065741611 - Trial 12mm: 2025-08-27 12mm Trial
• 00850065741628 - Distraction Paddle - 7mm: 2025-08-27 Distraction Paddle - 7mm
• 00850065741635 - Distraction Paddle - 8mm: 2025-08-27Distraction Paddle - 8mm
• 00850065741635 - Distraction Paddle - 8mm: 2025-08-27 Distraction Paddle - 8mm