Catalog Number

AM-006HR911

Brand Name

Patient Armor Barriers

Version/Model Number

Headrest Covers 11" x 9.5" x 2"

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

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

PEM

Product Code Name

Dental Barriers And Sleeves

Public Device Record Key

667ec6ea-8d1e-4599-b153-1fd7988b84a7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

10858653006095

Quantity per Package

12

Contains DI Package

00858653006098

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case