Always-On Trip Tracked Guidewire, 1.0mm, 735mm INS-0304

GUDID 10815686020436

VERAN MEDICAL TECHNOLOGIES INC.

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Primary Device ID10815686020436
NIH Device Record Keyf5b514a3-5366-4c7c-b345-d22d0da5ebb4
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlways-On Trip Tracked Guidewire, 1.0mm, 735mm
Version Model NumberINS-0304
Catalog NumberINS-0304
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 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
GS100815686020439 [Primary]
GS110815686020436 [Package]
Contains: 00815686020439
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 Steriletrue

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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