Bolt Navigation BN002-01-10

GUDID B981BN00201101

Bolt Navigation Sterile Case used with the Bolt Navigation System

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 IDB981BN00201101
NIH Device Record Key6b304b34-aa70-4b35-b56f-ae68675e6bdc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBolt Navigation
Version Model NumberBN002-01-10
Catalog NumberBN002-01-10
Company DUNS075673122
Company NameCircinus Medical Technology LLC
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com
Phone8666823422
Emailinfo@boltnav.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB981BN00201101 [Unit of Use]
HIBCCB981BN00201103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWBInterventional Fluoroscopic X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

On-Brand Devices [Bolt Navigation ]

B981BN00201101Bolt Navigation Sterile Case used with the Bolt Navigation System
B981BN0010101Bolt Navigation Unit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.