Catalog Number

PC88888116200S

Brand Name

MedStream

Version/Model Number

PC88888116200S

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

d35eeeb8-0e1f-4cd8-9fa7-9f319e2c5db1

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

May 04, 2018

Package DI Number

10842472106685

Quantity per Package

25

Contains DI Package

00842472106688

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-