Catalog Number

IMP-FX-08

Brand Name

IMPEDE-FX Embolization Plug

Version/Model Number

IMP-FX-08

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

0f82b926-b14e-40fa-9619-081a68107f2a

Public Version Date

April 08, 2022

Public Version Number

2

DI Record Publish Date

April 02, 2020

Package DI Number

10810041650044

Quantity per Package

1

Contains DI Package

00810041650047

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-