Rotablator™ Rotational Atherectomy System Console Kit 22020-039-L

GUDID 08714729719601

Rotational Atherectomy System

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: 08714729719601
• NIH Device Record Key: b58c2b98-5fb9-42ab-8b6f-0b179e8cdc52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotablator™ Rotational Atherectomy System Console Kit
• Version Model Number: 22020-039-L
• Catalog Number: 22020-039-L
• 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: true
• 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	08714729719601 [Primary]

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: 4
• Public Version Date: 2021-04-06
• Device Publish Date: 2014-09-24

On-Brand Devices [Rotablator™ Rotational Atherectomy System Console Kit]

• 08714729719601: Rotational Atherectomy System
• 08714729353300: Rotational Atherectomy System