ig4 System V2, 230V, 50Hz SYS-2230

GUDID 00815686020071

VERAN MEDICAL TECHNOLOGIES INC.

Electromagnetic surgical navigation device tracking system
Primary Device ID00815686020071
NIH Device Record Key106439f7-24d2-4747-a8a0-775a27b4f541
Commercial Distribution StatusIn Commercial Distribution
Brand Nameig4 System V2, 230V, 50Hz
Version Model NumberSYS-2230
Catalog NumberSYS-2230
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
GS100815686020071 [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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