Catalog Number

-

Brand Name

LensHooke semen Test Cassette

Version/Model Number

CS0_400pcs_BR USA CORP.

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

K202089

Product Code

POV

Product Code Name

Semen Analysis Device

Public Device Record Key

4735f006-62f8-46f8-bd39-0dd0585fbbe1

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-