RotaLink™ Burr H802227680150

GUDID 08714729185826

Exchangeable Burr Catheter

BOSTON SCIENTIFIC CORPORATION

Mechanical atherectomy system, coronary, line-powered

• Primary Device ID: 08714729185826
• NIH Device Record Key: 53b3af9d-71fc-49dd-8b84-c00c82e200c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RotaLink™ Burr
• Version Model Number: H802227680150
• Catalog Number: H802227680150
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729185826 [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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2021-04-06
• Device Publish Date: 2014-09-24

On-Brand Devices [RotaLink™ Burr]

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• 08714729185840: Exchangeable Burr Catheter
• 08714729185826: Exchangeable Burr Catheter
• 08714729185819: Exchangeable Burr Catheter
• 08714729185802: Exchangeable Burr Catheter
• 08714729185796: Exchangeable Burr Catheter
• 08714729126881: Exchangeable Burr Catheter