Catalog Number

-

Brand Name

EMBLEM™ S-ICD

Version/Model Number

3401

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

P110042,P110042

Product Code

LWS

Product Code Name

Implantable cardioverter defibrillator (non-CRT)

Public Device Record Key

61c8e21b-1ce2-49a3-9f65-02fb786e20f6

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

August 17, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-