Catalog Number

-

Brand Name

Scan

Version/Model Number

G-427BS

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K191657,K191657,K191657

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

ba412fe9-eb36-4aff-aae3-de0fbd2de6b5

Public Version Date

February 09, 2021

Public Version Number

1

DI Record Publish Date

February 01, 2021

Package DI Number

20860005561708

Quantity per Package

100

Contains DI Package

00860005561704

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack