Peripheral RotaLink® Plus

GUDID 08714729838937

Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device

BOSTON SCIENTIFIC CORPORATION

Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered Mechanical atherectomy system, coronary, line-powered

• Primary Device ID: 08714729838937
• NIH Device Record Key: 6184c6f7-f3c0-4618-ae4a-28211d3384e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peripheral RotaLink® Plus
• Version Model Number: M0011402150
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729838937 [Primary]

FDA Product Code

• MCW: Catheter, peripheral, atherectomy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Peripheral RotaLink® Plus]

• 08714729857808: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729838968: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729838951: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729838944: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729838937: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729838920: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729838913: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device
• 08714729838906: Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device