Catalog Number

IMP-FX-12

Brand Name

IMPEDE-FX Embolization Plug

Version/Model Number

IMP-FX-12

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

K182390,K182390

Product Code

KRD

Product Code Name

Device, Vascular, For Promoting Embolization

Public Device Record Key

97c52a32-5570-40bb-894f-211740b8a16d

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

April 02, 2020

Package DI Number

10810041650051

Quantity per Package

1

Contains DI Package

00810041650054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-