Catalog Number

CDOA-L9135NTA3

Brand Name

T-Cup Compact

Version/Model Number

CDOA-L9135NTA3

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

K133968,K152495,K133968,K152495,K152495,K133968

Product Code

DIO

Product Code Name

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

Public Device Record Key

e196a152-5406-4f0d-a6ae-57c0da19e38c

Public Version Date

October 31, 2022

Public Version Number

4

DI Record Publish Date

August 20, 2021

Package DI Number

10816862023296

Quantity per Package

4

Contains DI Package

00816862023299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-