FDA Registration
Active
🇺🇸 United States
Merit Medical Systems, Inc.
Reg #: 2032338
·
FEI: 3003295907
·
Expires 2026
Products
3
Proprietary Names
11
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Merit Medical Systems, Inc.
- Registration Number
- 2032338
- FEI Number
- 3003295907
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6 JOURNEY, SUITE 125
- City
- ALISO VIEJO
- State
- CA
- ZIP
- 92656
- Country
- US
Regulatory Submissions
- 510(k) Number
- K081677
Owner / Operator
- Firm Name
- Merit Medical Systems, Inc.
- Operator Number
- 1721504
- Address
- 1600 West Merit Parkway, --
- City
- South Jordan
- State
- UT
- Postal Code
- 84095
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2018-11-28 |
| Marker, Radiographic, Implantable | NEU | Class 2 | General, Plastic Surgery | No | 2024-11-04 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2021-01-27 |
Proprietary Names
SAVI Applicator Kit
SCOUT MD Console
SCOUT MD Single-use Handpieces
SCOUT MD Guides
SCOUT MD Delivery System
SCOUT Single-Use Handpiece, SCOUT Surgical Guides
SCOUT Reflector and Delivery Systems
SCOUT Surgical Console and SCOUT Check Console
SAVI Prep Device
SAVI Spacer
SCOUT Console and Accessory Cart
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility