Catalog Number

90168

Brand Name

Continuous Single Culture®–NX Complete

Version/Model Number

90168-60mL

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

-

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

-

FDA Premarket Submission

K170602

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

3f1f2ca6-5421-4df8-a8d2-81484fa8ca77

Public Version Date

April 23, 2021

Public Version Number

1

DI Record Publish Date

April 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-