Catalog Number

-

Brand Name

RADPAD

Version/Model Number

9911-O

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

IWT

Product Code Name

Shield, gonadal

Public Device Record Key

4f1ee955-c442-4c0a-ac21-9fd3762f039b

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

July 16, 2020

Package DI Number

10852814003572

Quantity per Package

15

Contains DI Package

00852814003575

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-