Identity
- Trade Name
- AMPLATZER™ FDA UDI
- Generic Name
- Cardiac defect occluder FDA UDI
- Device Name
- Septal Occluder FDA UDI
- Model / Reference
- 9-ASD-006 FDA UDI
- Description
- Septal Occluder FDA UDI
Identifiers
- Catalog Number
- 9-ASD-006 FDA UDI
- Primary DI / UDI-DI
- 05415067019141 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 6 Millimeter FDA UDI
Category: Cardiac defect occluder
Amplatzer™ by Aga Medical Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac defect occluder.
- Amplatzer Piccolo™ — ST. JUDE MEDICAL, INC. · Class III
- GORE CARDIOFORM Septal Occluder — W. L. GORE & ASSOCIATES, INC · Class III
- Amplatzer™ Amulet™ — ST. JUDE MEDICAL, INC. · Class III
- Occlutech ASD Occluder Procedure Pack — Occlutech International AB · Class III
- WATCHMAN FLX™ Pro — Boston Scientific · Class III
- Occlutech ASD Occluder — Occlutech GmbH · Class III
- Occlutech ASD Occluder Procedure Pack — Occlutech International AB · Class III
- WATCHMAN® — Boston Scientific · Class III
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
- Aga Medical Corp.
Sources (1)
- FDA UDI df0cea0d-a4b7-4ed2-8992-99821c57da4d 37 fields · synced Jun 6, 2026