Catalog Number

205216

Brand Name

MEDICOM SAFEMASK CLASSICS

Version/Model Number

205216

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FXX

Product Code Name

Mask, surgical

Public Device Record Key

965ec507-33ed-45d4-9c45-d4fe60a9cacb

Public Version Date

May 05, 2022

Public Version Number

2

DI Record Publish Date

April 16, 2021

Package DI Number

20686864057097

Quantity per Package

10

Contains DI Package

10686864057090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER CASE