ig4IR Software Application SFT-0004

GUDID 00815686021061

VERAN MEDICAL TECHNOLOGIES INC.

Electromagnetic surgical navigation device tracking system
Primary Device ID00815686021061
NIH Device Record Key2e3370b6-79fb-4d7a-8108-d6f06e06d12a
Commercial Distribution StatusIn Commercial Distribution
Brand Nameig4IR Software Application
Version Model NumberSFT-0004
Catalog NumberSFT-0004
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS100815686021061 [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

Devices Manufactured by VERAN MEDICAL TECHNOLOGIES INC.

00815686020460 - SPiN Vision Scope, 4.0mm OD, 2.0mm WC2023-02-20
00815686020415 - SPiN Vision Scope, 6.0mm OD, 3.0mm WC2023-02-20
00815686021320 - SPiN Vision Video Processor2023-02-20
10815686021174 - SPiN Access Catheter, 90 Degree Catheter2021-02-25
10815686021181 - SPiN Access Catheter Always-On Tip Tracked Guidewire2021-02-25
10815686021273 - SPiN Access Catheter, 90 Degrees For Use With Olympus 190 Scopes2021-02-25
00815686021283 - SPiN Access Catheter, 180 Degree Catheter2021-02-25
10815686021297 - SPiN Access Catheter, 180 Degrees For Use With Olympus 190 Scopes2021-02-25
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