Catalog Number

X QC Reticle

Brand Name

LensHooke X QC Reticle (For Semen)

Version/Model Number

X QC Reticle - 3 in1_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

-

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

NRF

Product Code Name

Material, Quality Control, Semen Analysis

Public Device Record Key

552fe199-5652-462c-8f35-c65b621b1129

Public Version Date

March 24, 2020

Public Version Number

1

DI Record Publish Date

March 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-