Catalog Number

-

Brand Name

Photonvue box

Version/Model Number

PVUE-TSC-1.0

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 08, 2018

Issuing Agency

In HIBCC

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

Yes

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

-

FDA Premarket Submission

K132475

Product Code

OWN

Product Code Name

Confocal Optical Imaging

Public Device Record Key

55f362ae-e150-4700-a825-af7c9b2ffd44

Public Version Date

February 01, 2022

Public Version Number

4

DI Record Publish Date

January 19, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-