Catalog Number

90167

Brand Name

Continuous Single Culture®–NX (CSCM–NX)

Version/Model Number

90167-20ML

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

Yes

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

-

FDA Premarket Submission

K170681

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

0b296e20-6a6b-4080-95a4-47b6e661fdef

Public Version Date

February 13, 2019

Public Version Number

4

DI Record Publish Date

July 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-