Anatase

GUDID 04719876737274

Probe

INTAI TECHNOLOGY CORP.

Orthopaedic stereotactic surgery system

• Primary Device ID: 04719876737274
• NIH Device Record Key: 8fc1c178-c975-4a48-8d98-f316f8cc8e9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anatase
• Version Model Number: NAVTL0004
• 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: 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
• 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
• 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	04719876737274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180523

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

[04719876737274]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-02-10
• Device Publish Date: 2023-01-30

On-Brand Devices [Anatase]

• 04719876757807: Spine Surgery Navigation System
• 04719876737274: Probe
• 04719876737267: Spine Clamp with DRF
• 04719876737106: Instrument Calibrator V Block
• 04719876737090: Drill Guide
• 04719876737083: Guiding AWL-R
• 04719876732460: Drill Bit
• 04719876732453: Guide Pin 540L
• 04719876732446: Releaser
• 04719876732439: Hex Key Wrench #3
• 04719876732422: Hex Key Wrench #2
• 04719876732415: Post Wrench
• 04719876732347: Palm Awl
• 04719876732330: T Ratchet Handle
• 04719876732323: Spine pin with DRF