Catalog Number

-

Brand Name

GLOBAL HEALTHCARE

Version/Model Number

83-C18

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JOL

Product Code Name

Catheter And Tip, Suction

Public Device Record Key

968bd2d9-9731-41b1-8631-31f6e93ce853

Public Version Date

August 06, 2020

Public Version Number

4

DI Record Publish Date

September 12, 2016

Package DI Number

40872237003288

Quantity per Package

10

Contains DI Package

20872237003284

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE