Catalog Number

652/1-110P

Brand Name

Bipolar 5FR 110cm Modified-J Shrouded Pins

Version/Model Number

606002

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

K930069

Product Code

LDF

Product Code Name

Electrode, Pacemaker, Temporary

Public Device Record Key

32347c6a-88c6-498b-aa06-380b70f5705d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-