Catalog Number

GSXA0015

Brand Name

Gore Septal Occluder

Version/Model Number

GSXA0015

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 24, 2018

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

P050006

Product Code

MLV

Product Code Name

Transcatheter Septal Occluder

Public Device Record Key

86f0503d-c927-4c3a-9bf2-f5715c5a4384

Public Version Date

April 08, 2022

Public Version Number

8

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-