Catalog Number

P33-10-MET

Brand Name

P33

Version/Model Number

P33-10-MET

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NFT

Product Code Name

Test, Amphetamine, Over The Counter

Public Device Record Key

3beae78b-03dd-41b9-b694-5813bf89f1f7

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 30, 2021

Package DI Number

00860004081661

Quantity per Package

4

Contains DI Package

00860004081654

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case