Catalog Number

80500

Brand Name

G-Rex

Version/Model Number

80500

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

KJF

Product Code Name

System, Suspension, Cell Culture

Public Device Record Key

e7ee697b-6b12-4b9a-b8f8-dccb4a88fd53

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Package DI Number

00850019717105

Quantity per Package

3

Contains DI Package

00850019717068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case