Catalog Number

GEFOB-602a

Brand Name

Healgen

Version/Model Number

GEFOB-602a

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)

Yes

Over the Counter (OTC)

Yes

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

11f8cae7-177b-40e3-8dd6-3fbeabaf651d

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

February 15, 2017

Package DI Number

20816490021159

Quantity per Package

50

Contains DI Package

10816490021152

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case