Bolt Navigation BN002-01-10

GUDID B981BN00201101

Surgical planning/navigation-enhancement system

Primary Device ID	B981BN00201101
NIH Device Record Key	6b304b34-aa70-4b35-b56f-ae68675e6bdc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Bolt Navigation
Version Model Number	BN002-01-10
Catalog Number	BN002-01-10
Company DUNS	075673122
Company Name	Circinus Medical Technology LLC
Device Count	10
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	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B981BN00201101 [Unit of Use]
HIBCC	B981BN00201103 [Primary]

OWB	Interventional Fluoroscopic X-Ray System

Steralize Prior To Use	false
Device Is Sterile	true

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