Catalog Number

CS-100-448-CK-1

Brand Name

Cellvizio® 100 series (488nm)

Version/Model Number

210-0027

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2020

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

K111047

Product Code

OWN

Product Code Name

Confocal Optical Imaging

Public Device Record Key

c58b7028-85e0-4f98-adf3-94317e682bd4

Public Version Date

May 07, 2020

Public Version Number

4

DI Record Publish Date

December 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-