Catalog Number

AM2200L

Brand Name

Patient Armor Ear Loop Masks

Version/Model Number

Orchid

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

0af96b69-047a-4af1-9d21-5fd75d61dd81

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

May 12, 2016

Package DI Number

10858653006187

Quantity per Package

10

Contains DI Package

00858653006180

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case