Catalog Number

382955

Brand Name

CELERITY

Version/Model Number

3D 75

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P070008

Product Code

OJX

Product Code Name

Drug eluting permanent left ventricular (lv) pacemaker electrode

Public Device Record Key

ce8ffdce-8230-4239-80b7-a9e0044c8632

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

August 19, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-