Catalog Number

145-0051

Brand Name

VS3 Iridium Fluorescence Vision System 785 110V- INS configuration - ELO

Version/Model Number

VS3-IR

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

K150018,K152204,K183453,K191851,K210265

Product Code

OWN

Product Code Name

Confocal Optical Imaging

Public Device Record Key

99b9c90e-1266-4ec8-ba5b-1d2a9c105b43

Public Version Date

July 13, 2022

Public Version Number

3

DI Record Publish Date

April 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-