VS3 Endoscope 4mm, Elbow, 0°, Wide FOV - VISIONSENSE LTD.

Duns Number:532199478

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More Product Details

Catalog Number

153-0006

Brand Name

VS3 Endoscope 4mm, Elbow, 0°, Wide FOV

Version/Model Number

VS3-NE

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 15, 2022

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K131434

Product Code Details

Product Code

GWG

Product Code Name

Endoscope, Neurological

Device Record Status

Public Device Record Key

1cce1564-eb3c-4d21-930e-fdd9272392f6

Public Version Date

June 13, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VISIONSENSE LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 77