Catalog Number

ARW01

Brand Name

Anti-Rotational Wedge for PRIMOBoot

Version/Model Number

ARW01

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

FMP

Product Code Name

Protector, Skin Pressure

Public Device Record Key

4655da5e-69d7-4625-a834-17f36982b9be

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 20, 2019

Package DI Number

10810006680000

Quantity per Package

24

Contains DI Package

00810006680003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case