Medtronic Retrieval Snare Kit System ONE1500-MDT

GUDID 10884450572129

Merit Medical Systems, Inc.

Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare

• Primary Device ID: 10884450572129
• NIH Device Record Key: 963d5bd7-3ffe-4011-b02c-2c340e1af05c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic Retrieval Snare Kit System
• Version Model Number: 00884450572122
• Catalog Number: ONE1500-MDT
• 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: true
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450572122 [Primary]
GS1	10884450572129 [Package]; Contains: 00884450572122; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122088

FDA Product Code

• MMX: Device, percutaneous retrieval

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: 2022-05-05
• Device Publish Date: 2022-04-27

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• 10884450697259 - ProGuide™: 2024-04-24
• 10884450712303 - Impress®: 2024-04-24
• 00884450819111 - Merit Medical®: 2024-04-24
• 20884450709188 - Prelude®: 2024-04-24