SPiNPlanning Software Application SFT-0010

GUDID 00815686021085

VERAN MEDICAL TECHNOLOGIES INC.

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Primary Device ID00815686021085
NIH Device Record Keya085adb0-79a4-4948-8b34-a62d852f3ec4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPiNPlanning Software Application
Version Model NumberSFT-0010
Catalog NumberSFT-0010
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
GS100815686021085 [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 Number5
Public Version Date2019-05-23
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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