Catalog Number

-

Brand Name

OC-Light S

Version/Model Number

FBPUS-EHICH

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

K143325

Product Code

KHE

Product Code Name

Reagent, Occult Blood

Public Device Record Key

9c143a2d-e8e1-4764-a018-d88f9f7245a4

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-