Catalog Number

-

Brand Name

Urine Collection Tube

Version/Model Number

Urinalaysis No Additive Tube

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

FMH

Product Code Name

Container, Specimen, Sterile

Public Device Record Key

a374ddc2-3d3d-412b-b470-3435f28e9133

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 09, 2022

Package DI Number

16974481837701

Quantity per Package

50

Contains DI Package

06974481837704

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-