ROTAPRO™

GUDID 08714729975076

Rotational Atherectomy System

BOSTON SCIENTIFIC CORPORATION

Mechanical atherectomy system, coronary, line-powered

• Primary Device ID: 08714729975076
• NIH Device Record Key: c9a85328-b6e2-4053-b153-6390471b946b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROTAPRO™
• Version Model Number: H74939309010
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729975076 [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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-04-06
• Device Publish Date: 2018-07-11

On-Brand Devices [ROTAPRO™]

• 08714729999638: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729999621: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729999614: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729999607: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729999591: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729999584: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729999577: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729999560: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729975106: Rotational Atherectomy System
• 08714729975090: Rotational Atherectomy System
• 08714729975083: Rotational Atherectomy System
• 08714729975076: Rotational Atherectomy System
• 08714729893424: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729893417: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729893400: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729893394: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729893387: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729893370: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729893363: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729893356: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device