Catalog Number

EPP01

Brand Name

Elbow Pillow Pad (Ripstop/Microsuede)

Version/Model Number

EPP01

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

e0d0f2d5-8dd6-4eeb-b7b6-63f78c4625ab

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

February 27, 2019

Package DI Number

00810006683042

Quantity per Package

12

Contains DI Package

00810006681642

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE