Identity
- Trade Name
- AMPLATZER™ FDA UDI
- Generic Name
- Cardiac occluder delivery kit FDA UDI
- Device Name
- Delivery Sheath FDA UDI
- Model / Reference
- 9-TV45X45-12F-100 FDA UDI
- Description
- Delivery Sheath FDA UDI
Identifiers
- Catalog Number
- 9-TV45X45-12F-100 FDA UDI
- Primary DI / UDI-DI
- 00811806012100 FDA UDI
- FDA Product Code
- DQY FDA UDI
- GMDN Term
- Cardiac occluder delivery kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Dimensions & Sizes
- Size
- Catheter Gauge — 12 French FDA UDI
Category: Cardiac occluder delivery kit
Amplatzer™ by Aga Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- FuStarTM Steerable introducer — Lifetech Scientific (Shenzhen) Co., Ltd. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Aga Medical Corp.
Sources (1)
- FDA UDI eeb087f9-ced5-4b90-99c0-3f3f26452084 37 fields · synced May 30, 2026