Catalog Number

VDCV100/C

Brand Name

Cultura™

Version/Model Number

10884450525767

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

3894d4e3-5a24-495d-a971-a0a558155910

Public Version Date

September 16, 2021

Public Version Number

1

DI Record Publish Date

September 08, 2021

Package DI Number

20884450525764

Quantity per Package

8

Contains DI Package

10884450525767

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-