Catalog Number

-

Brand Name

FORA

Version/Model Number

TN'G/TN'G Voice

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

K100322,K111890,K100322,K111890

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

30b49d4c-9ade-4d4d-8b99-ec7888a8229d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-