Catalog Number

625/1-110P

Brand Name

Bipolar 5FR 110cm Modified-J Shrouded Pins

Version/Model Number

652/1-110P

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

f0c72925-79f1-49ff-9665-f1bc8933e450

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-