Catalog Number

GEFA017300

Brand Name

GORE Embolic Filter

Version/Model Number

GEFA017300

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 11, 2019

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NTE

Product Code Name

Temporary Carotid Catheter for Embolic Capture

Public Device Record Key

ace858dc-f2c3-477c-a1b2-882012d52100

Public Version Date

December 12, 2019

Public Version Number

6

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-