Catalog Number

-

Brand Name

Opti-MEM® I Reduced Serum Medium

Version/Model Number

51985034

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 28, 2019

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

-

Product Code

KIT

Product Code Name

MEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE

Public Device Record Key

7729f4ca-cb13-44d9-a518-677001f0ab5e

Public Version Date

January 16, 2020

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

30190302004767

Quantity per Package

10

Contains DI Package

10190302004763

Package Discontinue Date

October 25, 2019

Package Status

Not in Commercial Distribution

Package Type

Case