ROTAPRO™ H749394671500

GUDID 08714729999577

Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device

BOSTON SCIENTIFIC CORPORATION

Mechanical atherectomy system, coronary, battery-powered

• Primary Device ID: 08714729999577
• NIH Device Record Key: 6d77431e-8bae-4a85-8f4e-dc5cde0d0696
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROTAPRO™
• Version Model Number: H749394671500
• Catalog Number: H749394671500
• Company DUNS: 021717889
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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

• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter
• Guidewire Diameter: 1.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729999577 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P900056

FDA Product Code

• MCX: CATHETER, CORONARY, ATHERECTOMY

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: 2020-07-09
• Device Publish Date: 2020-07-01

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• 08714729999584: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
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• 08714729999560: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
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• 08714729975090: Rotational Atherectomy System
• 08714729975083: Rotational Atherectomy System
• 08714729975076: Rotational Atherectomy System
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• 08714729893400: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
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• 08714729893387: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
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• 08714729893363: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729893356: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device