Catalog Number

BLV/BIS-4403

Brand Name

Lead Adaptor

Version/Model Number

664403-301

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 03, 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

K024156

Product Code

DTD

Product Code Name

pacemaker lead Adaptor

Public Device Record Key

05bfd9eb-aa3a-4255-a035-759911f05edf

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

November 21, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-