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Scout®

FDA UDI

Class II (US FDA UDI)

by Merit Medical Systems, Inc.

Identity

Trade Name
SCOUT® FDA UDI
Generic Name
Electromagnetic surgical navigation device tracking system FDA UDI
Model / Reference
L FDA UDI

Identifiers

Catalog Number
SG-01 FDA UDI
Primary DI / UDI-DI
00884450658505 FDA UDI
FDA Product Code
NEU FDA UDI
GMDN Term
Electromagnetic surgical navigation device tracking system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electromagnetic surgical navigation device tracking system

The SCOUT device is a cutting-edge, implantable electromagnetic surgical navigation system designed for various surgical procedures in fields such as ENT, craniomaxillofacial (CMF), laparoscopic, and orthopaedic surgery. It features advanced image registration and tracking capabilities, providing precise control over manual surgical instruments during complex surgeries. The SCOUT device is used to enhance patient outcomes and improve surgical results.

Similar devices

Also classified as Electromagnetic surgical navigation device tracking system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Merit Medical Systems, Inc.

Sources (1)

  • FDA UDI 1b9f8781-e109-4d47-bf6a-ce48882d5fa4 33 fields · synced Jul 19, 2026