Catalog Number

443-0001

Brand Name

VS3 Visionsense Camera Control Unit (CCU)

Version/Model Number

VS3-NE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131434,K150018,K152204,K183453,K191851,K210265

Product Code

OWN

Product Code Name

Confocal Optical Imaging

Public Device Record Key

d11d859a-aa43-4754-9700-d535e0e0d778

Public Version Date

July 13, 2022

Public Version Number

3

DI Record Publish Date

May 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-