Catalog Number

-

Brand Name

Sperm Collection Container

Version/Model Number

16102

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PUD

Product Code Name

Labware, Assisted Reproduction, Exempt

Public Device Record Key

a7291847-409e-444b-9aa9-0cb3ea36b8cc

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

April 30, 2021

Package DI Number

17350025914562

Quantity per Package

100

Contains DI Package

07350025914565

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-