Catalog Number

CDDRA300Q

Brand Name

Entrant™

Version/Model Number

CDDRA300Q

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

LWS

Product Code Name

Implantable cardioverter defibrillator (non-CRT)

Public Device Record Key

168a6ff7-4220-4dde-aad0-546b72981dcc

Public Version Date

February 23, 2022

Public Version Number

3

DI Record Publish Date

September 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-