Catalog Number

90165

Brand Name

Continuous Single Culture® Complete with Gentamicin Sulfate with Human Serum Alb

Version/Model Number

90165-60mL

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

Yes

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

-

FDA Premarket Submission

K121572

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

8c6ad6e8-5990-4819-a43d-74f56227035d

Public Version Date

June 30, 2021

Public Version Number

2

DI Record Publish Date

April 15, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-