Inliant 9000070

GUDID 00850049386029

Consumable - Fiducial Kit

Navigate Surgical Technologies Inc

Surgical planning/navigation-enhancement system

• Primary Device ID: 00850049386029
• NIH Device Record Key: c988554a-e7c1-41d9-85da-1e13370c0cf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Inliant
• Version Model Number: 900007-0
• Catalog Number: 9000070
• Company DUNS: 204920011
• Company Name: Navigate Surgical Technologies Inc
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com
• Phone: 16046374497
• Email: info@navigatesurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850049386029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213392

FDA Product Code

• PLV: Dental Stereotaxic Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-30
• Device Publish Date: 2023-10-20

On-Brand Devices [Inliant]

• 00850049386111: Inliant System, US, Full Package
• 00850049386029: Consumable - Fiducial Kit