Catalog Number

107235

Brand Name

S 53-K

Version/Model Number

107235

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

P950037,P950037

Product Code

NVN

Product Code Name

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

Public Device Record Key

21ba3dc3-65d5-4e3a-b493-8af1838d1219

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 14, 2014

Package DI Number

04035479000677

Quantity per Package

10

Contains DI Package

04035479145019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case