Catalog Number

7198

Brand Name

Costar

Version/Model Number

7198

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KIZ

Product Code Name

DISH, TISSUE CULTURE

Public Device Record Key

9c9e1f40-14df-489f-b680-a57e6c5d35ef

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

March 15, 2022

Package DI Number

H10871983

Quantity per Package

48

Contains DI Package

H10871981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-