Catalog Number

-

Brand Name

RADPAD

Version/Model Number

5511A-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

0d32ce3a-45c6-4a4f-8c92-fef2a24fb35d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 19, 2017

Package DI Number

20852814003463

Quantity per Package

2

Contains DI Package

10852814003466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-