Catalog Number

SS0100

Brand Name

Steradian Shield

Version/Model Number

SS0100

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EAK

Product Code Name

Screen, Leaded, Operator Radiation Protector

Public Device Record Key

6e8afc56-5042-4293-9eaa-0d1cd835ea51

Public Version Date

October 03, 2019

Public Version Number

1

DI Record Publish Date

September 25, 2019

Package DI Number

10853714008032

Quantity per Package

5

Contains DI Package

00853714008035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner pack