Catalog Number

10-320100

Brand Name

Ready Cells

Version/Model Number

10-320100

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

Yes

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

922ce6b2-3f44-4b82-8fb7-54be137cefa6

Public Version Date

October 29, 2018

Public Version Number

1

DI Record Publish Date

September 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-