Catalog Number

-

Brand Name

ColoScreen Developer

Version/Model Number

500091

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KHE

Product Code Name

REAGENT, OCCULT BLOOD

Public Device Record Key

be27c997-58a2-439d-bcc6-3d6507af6bed

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 18, 2016

Package DI Number

M52550771

Quantity per Package

20

Contains DI Package

M5255000910

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box