Catalog Number

-

Brand Name

Sperm Preparation Medium

Version/Model Number

10690060D

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

-

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

-

FDA Premarket Submission

K991332,K991332

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

9bc745e0-4053-4152-a7ce-0fcc17bcc29b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 22, 2016

Package DI Number

20888937800702

Quantity per Package

5

Contains DI Package

00888937800708

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-