OstialPRO® 3011/A

GUDID 10884450109448

Merit Medical Systems, Inc.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 10884450109448
• NIH Device Record Key: b29ac9bc-96cc-4144-827e-827861e2ee84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OstialPRO®
• Version Model Number: 00884450109441
• Catalog Number: 3011/A
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450109441 [Primary]
GS1	10884450109448 [Package]; Contains: 00884450109441; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122089

FDA Product Code

• DQX: WIRE, GUIDE, CATHETER

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

Devices Manufactured by Merit Medical Systems, Inc.

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• 00884450214657 - Merit Medical®: 2025-11-24
• 10884450787639 - Impress®: 2025-11-24
• 10884450787882 - Impress®: 2025-11-24
• 10884450788018 - Impress®: 2025-11-24
• 10884450788612 - Impress®: 2025-11-24
• 20884450115811 - Prelude IDeal™: 2025-11-24