Catalog Number

VCTS100/M

Brand Name

Cultura™

Version/Model Number

00884450525753

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JSM

Product Code Name

CULTURE MEDIA, NON-PROPAGATING TRANSPORT

Public Device Record Key

abd2e4d3-b06c-43c7-a4c1-d10bd84334db

Public Version Date

September 28, 2022

Public Version Number

1

DI Record Publish Date

September 20, 2022

Package DI Number

10884450525750

Quantity per Package

50

Contains DI Package

00884450525753

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-