Bolt Navigation BN001-01-01

GUDID B981BN0010101

Bolt Navigation Unit

Circinus Medical Technology LLC

Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system Surgical planning/navigation-enhancement system

• Primary Device ID: B981BN0010101
• NIH Device Record Key: 271df1e0-6086-4e20-af30-b16e9c354ccb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bolt Navigation
• Version Model Number: BN001-01-01
• Catalog Number: BN001-01-01
• Company DUNS: 075673122
• Company Name: Circinus Medical Technology LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com
• Phone: 8666823422
• Email: info@boltnav.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B981BN0010101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213768

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

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: 2023-03-23
• Device Publish Date: 2023-03-15

On-Brand Devices [Bolt Navigation ]

• B981BN00201101: Bolt Navigation Sterile Case used with the Bolt Navigation System
• B981BN0010101: Bolt Navigation Unit