Bolt Navigation BN002-02

GUDID BN981BN002023

Bolt Navigation Case

Circinus Medical Technology LLC

Surgical planning/navigation-enhancement system
Primary Device IDBN981BN002023
NIH Device Record Keya43de236-c46d-4a55-a172-f5d4a41afd3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBolt Navigation
Version Model NumberBN002-02
Catalog NumberBN002-02
Company DUNS075673122
Company NameCircinus Medical Technology LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCBN981BN002023 [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 Date2024-11-25
Device Publish Date2024-11-15

On-Brand Devices [Bolt Navigation ]

B981BN00201101Bolt Navigation Sterile Case used with the Bolt Navigation System
B981BN0010101Bolt Navigation Unit
BN981BN002023Bolt Navigation Case
BN981BN001021Bolt Navigation Unit, Gen 2.0

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