Identity
- Trade Name
- GORE CARDIOFORM ASD Occluder FDA UDI
- Generic Name
- Cardiac defect occluder FDA UDI
- Device Name
- GORE CARDIOFORM ASD Occluder 44 mm 10Fr FDA UDI
- Model / Reference
- ASD44A FDA UDI
- Description
- GORE CARDIOFORM ASD Occluder 44 mm 10Fr FDA UDI
Identifiers
- Catalog Number
- ASD44A FDA UDI
- Primary DI / UDI-DI
- 00733132636518 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
- 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
Yes
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 44 Millimeter FDA UDI
Category: Cardiac defect occluder
GORE CARDIOFORM ASD Occluder by W. L. Gore & Associates, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac defect occluder.
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- AMPLATZER™ — Aga Medical Corp. · Class III
- Amplatzer™ — Aga Medical Corp. · Class III
- Amplatzer™ — Aga Medical Corp. · Class III
- Occlutech ASD Occluder — Occlutech GmbH · Class III
Cleared under the same submission
P050006 also covers:
- GORE CARDIOFORM ASD Occluder — W. L. GORE & ASSOCIATES, INC
- GORE CARDIOFORM ASD Occluder — W. L. GORE & ASSOCIATES, INC
- GORE CARDIOFORM ASD Occluder — W. L. GORE & ASSOCIATES, INC
- GORE CARDIOFORM ASD Occluder — W. L. GORE & ASSOCIATES, INC
- GORE CARDIOFORM Septal Occluder — W. L. GORE & ASSOCIATES, INC
- GORE CARDIOFORM Septal Occluder — W. L. GORE & ASSOCIATES, INC
- GORE CARDIOFORM Septal Occluder — W. L. GORE & ASSOCIATES, INC
- GORE CARDIOFORM Septal Occluder — W. L. GORE & ASSOCIATES, INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- W. L. Gore & Associates, Inc
Sources (1)
- FDA UDI 8b1b0b73-1106-4830-98b9-60803e5150ba 38 fields · synced May 30, 2026