ig4 System V2, 120V, 60Hz SYS-2000

GUDID 00815686020064

VERAN MEDICAL TECHNOLOGIES INC.

Electromagnetic surgical navigation device tracking system
Primary Device ID00815686020064
NIH Device Record Key5551084b-e9c8-4d7c-b5ad-a14084cc70ae
Commercial Distribution StatusIn Commercial Distribution
Brand Nameig4 System V2, 120V, 60Hz
Version Model NumberSYS-2000
Catalog NumberSYS-2000
Company DUNS181714804
Company NameVERAN MEDICAL TECHNOLOGIES INC.
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815686020064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JAKSystem, X-Ray, Tomography, Computed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

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