Catalog Number

SSB-148

Brand Name

STATSWAB®

Version/Model Number

SSB-148

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PVA

Product Code Name

Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt

Public Device Record Key

7dec1f11-ac04-45d9-943a-910f116e6a43

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-