FDA Registration Active 🇺🇸 United States

SCOUT Surgical Console and SCOUT Check Console

Reg #: 2032338 · FEI: 3003295907 · Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Merit Medical Systems, Inc.
Registration Number
2032338
FEI Number
3003295907
Status
Active
Expiry Year
2025
Initial Importer
No
Address
6 JOURNEY, SUITE 125
City
ALISO VIEJO
State
CA
ZIP
92656
Country
US

Regulatory Submissions

510(k) Number
K181007

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
Marker, Radiographic, Implantable NEU

Proprietary Names

SCOUT Surgical Console and SCOUT Check Console SCOUT Single-Use Handpiece, SCOUT Surgical Guides SCOUT Reflector and Delivery Systems

Establishment Types

Develop Specifications But Do Not Manufacture At This Facility