Anatase Spine Surgery Navigation System

GUDID 04719876737120

TAP 5.5D

INTAI TECHNOLOGY CORP.

Bone tap, reusable

• Primary Device ID: 04719876737120
• NIH Device Record Key: edecf7dc-2903-41df-a08a-710bc7a6b561
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anatase Spine Surgery Navigation System
• Version Model Number: INS-TAP55D
• Company DUNS: 658683227
• Company Name: INTAI TECHNOLOGY CORP.
• 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: true
• 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

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
• 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	04719876737120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220348

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

[04719876737120]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-11
• Device Publish Date: 2023-08-03

On-Brand Devices [Anatase Spine Surgery Navigation System]

• 04719876737250: TAP 5.0D
• 04719876737120: TAP 5.5D