SCOUT CHECK® CHKHP-01/B

GUDID 10884450434465

MERIT MEDICAL SYSTEMS, INC.

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 10884450434465
• NIH Device Record Key: a4e1e74e-5c56-4eba-bc4e-68bbbd1e602a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCOUT CHECK®
• Version Model Number: 00884450434468
• Catalog Number: CHKHP-01/B
• Company DUNS: 117056277
• Company Name: MERIT MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450434468 [Primary]
GS1	10884450434465 [Package]; Contains: 00884450434468; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181007

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-04
• Device Publish Date: 2021-09-24

Devices Manufactured by MERIT MEDICAL SYSTEMS, INC.

• 20884450643840 - SCOUT MD™: 2025-01-16
• 10884450709389 - Impress®: 2025-01-16
• 10884450788681 - Impress®: 2025-01-16
• 10884450789046 - Impress®: 2025-01-16
• 10884450793203 - BioFlo DuraMax®: 2025-01-16
• 10884450826437 - Fountain®: 2025-01-16
• 10884450643720 - SCOUT MD™: 2025-01-15
• 10884450643737 - SCOUT MD™: 2025-01-15