vPad2 Patient Tracker INS-0050

GUDID 10815686020405

VERAN MEDICAL TECHNOLOGIES INC.

Electromagnetic device tracking system fiducial marker Electromagnetic device tracking system fiducial marker Electromagnetic device tracking system fiducial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker Electromagnetic device tracking system spatial marker
Primary Device ID10815686020405
NIH Device Record Keyb60bb941-957b-400c-8d92-43fdbfba8e15
Commercial Distribution StatusIn Commercial Distribution
Brand NamevPad2 Patient Tracker
Version Model NumberINS-0050
Catalog NumberINS-0050
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 Usetrue
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
GS100815686020408 [Primary]
GS110815686020405 [Package]
Contains: 00815686020408
Package: [5 Units]
In Commercial Distribution

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.

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10815686021174 - SPiN Access Catheter, 90 Degree Catheter2021-02-25
10815686021181 - SPiN Access Catheter Always-On Tip Tracked Guidewire2021-02-25
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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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