Catalog Number

-

Brand Name

McCoy's 5A (Modified) Medium with GlutaMAX™ Supplement

Version/Model Number

36600021

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 17, 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

c02b1499-9d45-4e7a-b8bc-4847d7f60ed9

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

August 01, 2016

Package DI Number

30190302004446

Quantity per Package

10

Contains DI Package

10190302004442

Package Discontinue Date

October 16, 2019

Package Status

Not in Commercial Distribution

Package Type

Case