Catalog Number

124871

Brand Name

A1-CS-SB

Version/Model Number

124871

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 16, 2020

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

K003454

Product Code

DTD

Product Code Name

pacemaker lead Adaptor

Public Device Record Key

3c35f605-bbd1-4db1-a740-4a94c4432e60

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

August 27, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-