Catalog Number

KPRO10

Brand Name

KerraPro

Version/Model Number

4 x 4 x 0.1 in

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

-

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

a292876c-08f0-4c44-b5ee-2910a92ce009

Public Version Date

September 09, 2020

Public Version Number

2

DI Record Publish Date

October 01, 2019

Package DI Number

05060077234093

Quantity per Package

32

Contains DI Package

05060077230385

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shipper