Catalog Number

V004030

Brand Name

VitaVitro

Version/Model Number

30ml

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

K191063

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

1c7517c2-e720-436d-9a5c-b0e7137a7365

Public Version Date

November 13, 2019

Public Version Number

3

DI Record Publish Date

September 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-