Catalog Number

AM-006TS1014

Brand Name

Patient Armor Barriers

Version/Model Number

Tray Sleeves- Size B 10-1/2" x 14"

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

PEM

Product Code Name

Dental Barriers And Sleeves

Public Device Record Key

5f43f97a-2ea1-4d57-a08f-b41aaa97f98f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

10858653006132

Quantity per Package

6

Contains DI Package

00858653006135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case