Catalog Number

FGA00175

Brand Name

WEB Detachment Controller

Version/Model Number

WDC-1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

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,P170032

Product Code

OPR

Product Code Name

Intrasaccular Flow Disruption Device

Public Device Record Key

d9d013c6-b968-4bac-803e-31468d9ccbbe

Public Version Date

January 04, 2021

Public Version Number

3

DI Record Publish Date

April 01, 2019

Package DI Number

10856956005289

Quantity per Package

5

Contains DI Package

00856956005282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box of 5