Catalog Number

-

Brand Name

Sperm-TIC 1:20 plus

Version/Model Number

003604-6100

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

JCG

Product Code Name

Fluid, Diluting, Manual Cell

Public Device Record Key

1c81a873-de5e-4578-b0b7-4d14c230887c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-