View Optical Probe INS-5500

GUDID 00815686020729

VERAN MEDICAL TECHNOLOGIES INC.

Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use
Primary Device ID00815686020729
NIH Device Record Keydcfa9a52-1a59-47cd-8100-6877d0ef06c7
Commercial Distribution StatusIn Commercial Distribution
Brand NameView Optical Probe
Version Model NumberINS-5500
Catalog NumberINS-5500
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
GS100815686020729 [Primary]
GS110815686020726 [Package]
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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.