Catalog Number

4900

Brand Name

MEDICOM

Version/Model Number

4900

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 26, 2022

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

093f8df8-eb5d-435a-bb11-99eded4358f7

Public Version Date

January 27, 2022

Public Version Number

8

DI Record Publish Date

September 11, 2016

Package DI Number

20686864869829

Quantity per Package

200

Contains DI Package

10686864869822

Package Discontinue Date

January 26, 2022

Package Status

Not in Commercial Distribution

Package Type

OUTER CASE