Catalog Number

SSV020

Brand Name

SureStep Vacutainer Urine Sampling Kit

Version/Model Number

SSV020

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

OIE

Product Code Name

Urine collection kit (excludes HIV testing)

Public Device Record Key

b24c0f13-1e06-49d9-9f21-b920ed14d8ba

Public Version Date

September 11, 2020

Public Version Number

1

DI Record Publish Date

September 03, 2020

Package DI Number

10801741188876

Quantity per Package

1

Contains DI Package

00801741188879

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA