SPiN Access Catheter, 90 Degrees For Use With Pentax Scopes INS-5920

GUDID 10815686021303

VERAN MEDICAL TECHNOLOGIES INC.

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Primary Device ID10815686021303
NIH Device Record Key72b89c7b-b39b-4c11-bb6a-34e2a8b89853
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPiN Access Catheter, 90 Degrees For Use With Pentax Scopes
Version Model NumberINS-5920
Catalog NumberINS-5920
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
GS100815686021306 [Primary]
GS110815686021303 [Package]
Contains: 00815686021306
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-25
Device Publish Date2021-02-17

Devices Manufactured by VERAN MEDICAL TECHNOLOGIES INC.

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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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