Catalog Number

1502

Brand Name

Bullseye Urine

Version/Model Number

1502

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

JSJ

Product Code Name

CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL

Public Device Record Key

81c9167e-d2b9-46d2-9e1c-c319c59194d5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

M20215022

Quantity per Package

12

Contains DI Package

M20215021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box