Catalog Number

383584

Brand Name

Ilesto 5 VR-T

Version/Model Number

383584

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 24, 2021

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

-

Product Code

LWS

Product Code Name

Implantable cardioverter defibrillator (non-CRT)

Public Device Record Key

9b00258b-a405-47a6-aa57-9d41d81c9737

Public Version Date

August 25, 2021

Public Version Number

6

DI Record Publish Date

August 06, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-