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GORE HELEX Septal Occluder

FDA UDI

Class III (US FDA UDI)

by W. L. Gore & Associates, Inc

Identity

Trade Name
GORE HELEX Septal Occluder FDA UDI
Generic Name
Cardiac defect occluder FDA UDI
Model / Reference
HX2015 FDA UDI

Identifiers

Primary DI / UDI-DI
00733132606979 FDA UDI
PMA Number
P050006 FDA UDI
FDA Product Code
MLV FDA UDI
GMDN Term
Cardiac defect occluder FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Dimensions & Sizes

Size
Length — 75 Centimeter FDA UDI
Outer Diameter — 15 Millimeter FDA UDI

GORE HELEX Septal Occluder by W. L. Gore & Associates, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P050006 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
W. L. Gore & Associates, Inc

Sources (1)

  • FDA UDI 02e93e35-d683-495f-a219-d1126ad827dc 36 fields · synced Jun 8, 2026