Catalog Number

-

Brand Name

Globe Scientific

Version/Model Number

5505

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

194e5eaf-0b84-4e34-a631-f3df3808d529

Public Version Date

January 22, 2021

Public Version Number

2

DI Record Publish Date

November 26, 2019

Package DI Number

00840095607674

Quantity per Package

8

Contains DI Package

00840095607667

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case