Catalog Number

392423

Brand Name

Iperia 7 DR-T

Version/Model Number

392423

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 16, 2020

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

MRM

Product Code Name

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER

Public Device Record Key

c083cc2e-1b6a-43ba-bfc4-59d304f9f405

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

January 07, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-