Catalog Number

-

Brand Name

n.a.

Version/Model Number

20133720-1

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

K152583

Product Code

OWN

Product Code Name

Confocal optical imaging

Public Device Record Key

3caa438b-06de-4896-b64f-c2936ed67a2c

Public Version Date

December 22, 2021

Public Version Number

5

DI Record Publish Date

October 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-