Catalog Number

V01501280

Brand Name

VitaVitro

Version/Model Number

Sperm Gradient Medium SG-80, 12 mL

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K212410

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

4fa54fda-f880-4f95-8ac5-95e936a59821

Public Version Date

February 21, 2022

Public Version Number

1

DI Record Publish Date

February 11, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-