Bolt Navigation BN001-01-01

GUDID B981BN0010101

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

Device Issuing Agency	Device ID
HIBCC	B981BN0010101 [Primary]

OWB	Interventional Fluoroscopic X-Ray System

Steralize Prior To Use	false
Device Is Sterile	false

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