Catalog Number

C0992070

Brand Name

Steelex

Version/Model Number

C0992070

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

LDF

Product Code Name

ELECTRODE, PACEMAKER, TEMPORARY

Public Device Record Key

343632bd-ad4a-4813-acdd-13bbc2d98c13

Public Version Date

April 28, 2022

Public Version Number

7

DI Record Publish Date

August 16, 2015

Package DI Number

04046964356919

Quantity per Package

30

Contains DI Package

04038653915408

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton