Catalog Number

TNR IFOB

Brand Name

Tanner Scientific®

Version/Model Number

TNR IFOB

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

-

Product Code

KHE

Product Code Name

Reagent, Occult Blood

Public Device Record Key

5d1f0c89-4d1f-4f18-8054-91f50ff2bf01

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

August 15, 2016

Package DI Number

10850011007157

Quantity per Package

20

Contains DI Package

00850011007150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack