Catalog Number

-

Brand Name

RADPAD

Version/Model Number

5300A-R

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

KPY

Product Code Name

Shield, protective, personnel

Public Device Record Key

33a0fbc6-87ed-45a4-9c34-960e6142cdbc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 18, 2017

Package DI Number

20852814003388

Quantity per Package

2

Contains DI Package

10852814003381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-