Mistique®

GUDID 10884450012151

Merit Medical Systems, Inc.

Polymer-metal oesophageal stent, non-sterile

• Primary Device ID: 10884450012151
• NIH Device Record Key: 54961a0a-b7fc-42db-8838-4bc30415e45a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mistique®
• Version Model Number: 00884450012154
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450012154 [Primary]
GS1	10884450012151 [Package]; Contains: 00884450012154; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974067

FDA Product Code

• KRA: Catheter, continuous flush

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Mistique®]

• 10884450012151: 00884450012154
• 10884450012144: 00884450012147
• 10884450012120: 00884450012123
• 10884450012113: 00884450012116
• 10884450012090: 00884450012093
• 10884450012083: 00884450012086