SCOUT® SG-01/B

GUDID 00884450434710

MERIT MEDICAL SYSTEMS, INC.

Electromagnetic surgical navigation device tracking system

• Primary Device ID: 00884450434710
• NIH Device Record Key: 7d30cbe5-ac9f-4d01-9207-5a5396d8ae16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCOUT®
• Version Model Number: 00884450434710
• Catalog Number: SG-01/B
• Company DUNS: 117056277
• Company Name: MERIT MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450434710 [Primary]

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: 2019-11-20
• Device Publish Date: 2019-11-12

On-Brand Devices [SCOUT®]

• 10884450434816: 00884450434819
• 00884450434710: 00884450434710
• 10852205006106: 00852205006109
• 10884450435851: 00884450435854
• 10884450435837: 00884450435830
• 10884450435011: 00884450435014
• 10884450433895: 00884450433898
• 10884450435868: 00884450435861
• 10884450493325: 00884450493328
• 10884450493318: 00884450493311
• 20884450434790: 00884450434796
• 20884450434783: 00884450434789
• 20884450434769: 00884450434765
• 10884450434984: 00884450434987
• 20884450434912: 00884450434918
• 20884450434875: 00884450434871
• 10884450500351: 00884450500354
• 10884450500573: 00884450500576
• 20884450435032: 00884450435038
• 20884450530201: 00884450530207
• 20884450530218: 00884450530214
• 10884450530228: 00884450530221
• 10884450434960: 00884450434963
• 00884450551981: 00884450551981
• 10884450464462: 00884450464465
• 20884450500600: 00884450500606
• 10884450434731: 00884450434734
• 00884450500118: 00884450500118
• 20884450434943: 00884450434949
• 20884450434899: 00884450434895
• 10884450433956: 00884450433959
• 10884450508142: 00884450508145
• 10884450530242: 00884450530245
• 10884450500597: 00884450500590
• 10884450500627: 00884450500620
• 20884450500549: 00884450500545
• 10884450450588: 00884450450581
• 10884450433987: 00884450433980
• 20884450500563: 00884450500569
• 10884450500535: 00884450500538
• 00884450530139: D
• 00884450530122: 00884450530122
• 00884450658512: L
• 20884450582835: 00884450582831
• 10884450582760: 00884450582763
• 10884450582852: 00884450582855
• 10884450500610: 00884450500613
• 10884450582715: 00884450582718
• 20884450500587: G
• 10884450500559: G