Catalog Number

9984

Brand Name

Modified Sperm Washing Medium

Version/Model Number

9984-12X12mL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 16, 2021

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

K983588,K983588

Product Code

MQL

Product Code Name

Media, Reproductive

Public Device Record Key

4cdaa72d-541e-44c5-b9b3-d99c9855fda0

Public Version Date

April 16, 2021

Public Version Number

6

DI Record Publish Date

September 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-