GORE HELEX Septal Occluder

GUDID H373HX202534

W. L. Gore & Associates, Inc.

Cardiac occluder
Primary Device IDH373HX202534
NIH Device Record Key300610eb-fa72-4fde-9422-2e40280dfe84
Commercial Distribution Discontinuation2016-03-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameGORE HELEX Septal Occluder
Version Model NumberHX2025
Company DUNS967358115
Company NameW. L. Gore & Associates, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com
Phone8005288763
Emailmpdcustomercare@wlgore.com

Device Dimensions

Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter
Length75 Centimeter
Outer Diameter25 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100733132606993 [Primary]
HIBCCH373HX202534 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MLVTranscatheter Septal Occluder

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-13

On-Brand Devices [GORE HELEX Septal Occluder]

H373HX203535HX2035
H373HX203030HX2030
H373HX202534HX2025
H373HX20203HX2020
H373HX201533HX2015

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