VS3 Coupler for 2D Endoscopes 174-0020

GUDID 18130400103212

VISIONSENSE LTD.

Endoscope video camera
Primary Device ID18130400103212
NIH Device Record Key2c0975b0-2e7e-4a37-a40a-681c9016538c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVS3 Coupler for 2D Endoscopes
Version Model NumberVS3-NE
Catalog Number174-0020
Company DUNS532199478
Company NameVISIONSENSE LTD.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS118130400103212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18130400103212]

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[18130400103212]

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[18130400103212]

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[18130400103212]

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[18130400103212]

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[18130400103212]

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[18130400103212]

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[18130400103212]

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[18130400103212]

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Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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10884521816718 - VS3-IR2024-11-19 153-0074 VS3 IR ENDOSCOPE 10MM 30DEG
10884521816725 - VS3-IR2024-11-19 153-0075 VS3 IR ENDOSCOPE 10MM 0DEG
10884521821187 - VS3-NE2024-11-19 VS3 Visionsense Camera Control Unit (CCU)
10884521844681 - VS3 Iridium2024-11-19 VS3 Iridium - Miniature Microscope, 785nm (MMS-IR)
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