Mighty Wire™ MW352604J

GUDID 10884450563981

Merit Medical Systems, Inc.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 10884450563981
• NIH Device Record Key: f977de4c-3729-49a7-9f3d-de1ae5c843cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mighty Wire™
• Version Model Number: Initial Release
• Catalog Number: MW352604J
• Company DUNS: 184763290
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450563984 [Primary]
GS1	10884450563981 [Package]; Contains: 00884450563984; Package: [5 Units]; In Commercial Distribution
GS1	20884450563988 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230418

FDA Product Code

• DQX: Wire, guide, catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-03
• Device Publish Date: 2024-03-26

On-Brand Devices [Mighty Wire™]

• 10884450564087: Initial Release
• 20884450564053: Initial Release
• 20884450564060: Initial Release
• 10884450564001: Initial Release
• 20884450563933: Initial Release
• 10884450563981: Initial Release
• 20884450563964: Initial Release
• 10884450563998: Initial Release