Catalog Number

-

Brand Name

FORA

Version/Model Number

MD

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

K101509,K101509

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

866208da-9bfa-4e2c-bf2e-d606834f2c9a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-