Catalog Number

-

Brand Name

Sterimed

Version/Model Number

3692

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

f9423058-6aa6-4ef2-932f-17ac9979776d

Public Version Date

February 06, 2020

Public Version Number

2

DI Record Publish Date

December 05, 2018

Package DI Number

10867878000481

Quantity per Package

25

Contains DI Package

00867878000484

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack/Box