Identity
- Trade Name
- Amulet™ FDA UDI
- Generic Name
- Cardiac occluder delivery kit FDA UDI
- Device Name
- Steerable Delivery Sheath FDA UDI
- Model / Reference
- STRBL-14F-075 FDA UDI
- Description
- Steerable Delivery Sheath FDA UDI
Identifiers
- Catalog Number
- STRBL-14F-075 FDA UDI
- Primary DI / UDI-DI
- 05415067049094 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 — 14.0000 French FDA UDILength — 75.0000 Centimeter FDA UDI
Category: Cardiac occluder delivery kit
Amulet™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Cardiac occluder delivery kit.
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- FuStarTM Steerable introducer — Lifetech Scientific (Shenzhen) Co., Ltd. · Class II
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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
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 6281d7d8-e7b1-4a43-954a-60113b96baed 38 fields · synced May 30, 2026