Catalog Number

FGA15100-050

Brand Name

WEB Aneurysm Embolization System

Version/Model Number

W2-10-5

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"

Yes

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

P170032

Product Code

OPR

Product Code Name

Intrasaccular Flow Disruption Device

Public Device Record Key

09eb387c-f409-4740-84f0-e6be6d2c3f35

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

April 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-