Catalog Number

383550

Brand Name

Ilesto 5 HF-T

Version/Model Number

383550

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 23, 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

NIK

Product Code Name

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

Public Device Record Key

021ad7f1-30d1-4641-b567-48b4edc1db2a

Public Version Date

August 24, 2021

Public Version Number

6

DI Record Publish Date

August 07, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-