Catalog Number

-

Brand Name

Sterimed

Version/Model Number

PC0512

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

7007051e-8141-46c7-9333-2c78ef904f23

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 24, 2017

Package DI Number

10850341007971

Quantity per Package

25

Contains DI Package

00850341007974

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack/Box