Catalog Number

G0992097

Brand Name

Steelex

Version/Model Number

G0992097

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

01601c8a-e669-4eba-baec-2ebe47746ebd

Public Version Date

April 28, 2022

Public Version Number

8

DI Record Publish Date

August 20, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-