Catalog Number

-

Brand Name

Sterimed

Version/Model Number

3520SB

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IZI

Product Code Name

System, X-Ray, Angiographic

Public Device Record Key

7497a96c-7986-42d2-81a3-15681ed27310

Public Version Date

May 05, 2020

Public Version Number

1

DI Record Publish Date

April 27, 2020

Package DI Number

10860001790211

Quantity per Package

300

Contains DI Package

00860001790214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case