Catalog Number

C-60500N-3A

Brand Name

NexScreen Cup

Version/Model Number

C-60500N-3A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 20, 2019

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

K082898

Product Code

NFT

Product Code Name

Test, Amphetamine, Over The Counter

Public Device Record Key

c98b923b-66fe-430f-87e0-06df320d7219

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

September 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-