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US
Last updated May 25, 2026
What SACRED HEART MEDICAL, INC. makes
Sacred Heart Medical, Inc. manufactures single-use urinary stone retrieval baskets designed for percutaneous nephrolithotomy (PCNL) and ureteroscopy procedures. These devices include various models such as the 6-Wire Halo, Apex, Halo Trinity, Vantage, and Hercules, each engineered for the removal of kidney and ureteral stones during minimally invasive surgeries.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Sacred Heart Medical, Inc. manufacture?
Sacred Heart Medical, Inc. specializes in single-use urinary stone retrieval baskets. These devices are specifically designed for percutaneous nephrolithotomy (PCNL) and ureteroscopy procedures, where they assist in removing kidney and ureteral stones during minimally invasive surgeries. Examples include models like the 6-Wire Halo, Apex, Halo Trinity, Vantage, and Hercules.
Where is Sacred Heart Medical, Inc. based?
Sacred Heart Medical, Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory jurisdiction and operational base, particularly when reviewing compliance or device listings.
How are the devices manufactured by Sacred Heart Medical, Inc. classified under FDA regulations?
The devices produced by Sacred Heart Medical, Inc., such as their urinary stone retrieval baskets, are classified as Class II medical devices under FDA regulations. This classification typically indicates moderate risk and requires special controls to ensure safety and effectiveness, though it does not require a premarket approval (PMA) application like Class III devices.
Are Sacred Heart Medical, Inc.’s devices listed in any regulatory databases?
Yes, the devices manufactured by Sacred Heart Medical, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. This database helps track and identify medical devices through standardized identifiers, ensuring transparency and traceability in the regulatory and clinical settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 832763002
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Biliary Stone Basket | 50024 | FDA UDI | Class II | Unknown |
| 6-Wire Halo | 556160 | FDA UDI | Class II | Active |
| Apex | 544310 | FDA UDI | Class II | Active |
| Halo Trinity | 556130 | FDA UDI | Class II | Active |
| Halo | 555020 | FDA UDI | Class II | Active |
| Vantage | 550320 | FDA UDI | Class II | Active |
| Apex | 544320 | FDA UDI | Class II | Active |
| Vantage | 550310 | FDA UDI | Class II | Unknown |
| Hercules | 530525 | FDA UDI | Class II | Active |
| Hercules | 530520 | FDA UDI | Class II | Active |
| Summit | 342515 | FDA UDI | Class II | Unknown |
| Halo | 554120 | FDA UDI | Class II | Active |
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