Catalog Number

18573

Brand Name

MedStream

Version/Model Number

18573

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

Yes

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

-

FDA Premarket Submission

-

Product Code

OXQ

Product Code Name

Dressing Change Tray

Public Device Record Key

91357356-8b05-462b-8e5e-4b98eab51e11

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

April 10, 2018

Package DI Number

10842472106579

Quantity per Package

20

Contains DI Package

00842472106572

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-