SPiN Vision Scope, 4.0mm OD, 2.0mm WC INS-7100

GUDID 00815686020460

VERAN MEDICAL TECHNOLOGIES INC.

Flexible video bronchoscope, single-use
Primary Device ID00815686020460
NIH Device Record Keyec8c7309-f214-4d04-99ec-47c346d94b8a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPiN Vision Scope, 4.0mm OD, 2.0mm WC
Version Model NumberINS-7100
Catalog NumberINS-7100
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
GS100815686020460 [Primary]
GS110815686021334 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-20
Device Publish Date2023-02-11

Devices Manufactured by VERAN MEDICAL TECHNOLOGIES INC.

00815686020460 - SPiN Vision Scope, 4.0mm OD, 2.0mm WC2023-02-20
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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