Catalog Number

-

Brand Name

Globe Scientific

Version/Model Number

2912

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 17, 2021

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

LIB

Product Code Name

Device, General Purpose, Microbiology, Diagnostic

Public Device Record Key

e39b72b6-fb0a-42dc-834c-93df88e9b903

Public Version Date

December 08, 2021

Public Version Number

4

DI Record Publish Date

November 26, 2019

Package DI Number

00840095604956

Quantity per Package

10

Contains DI Package

00840095604949

Package Discontinue Date

November 17, 2021

Package Status

Not in Commercial Distribution

Package Type

Case