Catalog Number

-

Brand Name

Globe Scientific

Version/Model Number

6618

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

LXG

Product Code Name

Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Public Device Record Key

06c65f58-bc3d-45ea-9abd-f82ab1793657

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

November 26, 2019

Package DI Number

00840095608350

Quantity per Package

12

Contains DI Package

00840095608343

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case