Rotablator™

GUDID 08714729353317

Dynaglide™ Foot Pedal

BOSTON SCIENTIFIC CORPORATION

Mechanical atherectomy system, coronary, line-powered

• Primary Device ID: 08714729353317
• NIH Device Record Key: bc47e070-9c46-4f65-acbb-a811e1077ed8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rotablator™
• Version Model Number: H802224360021
• 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	08714729353317 [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

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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• 00191506043964 - FARASTAR™: 2026-01-28 EGM to EP Recording System Cable (FARAPOINT™)
• 00191506047207 - FARAPOINT™: 2026-01-28 Pulsed Field Ablation Catheter
• 00191506047221 - FARAPOINT™: 2026-01-28 Pulsed Field Ablation Catheter
• 00191506055073 - FARASTAR™: 2026-01-28 Inter-Connection Box
• 00191506057688 - FARASTAR™: 2026-01-28 Pulsed Field Ablation Generator
• 08714729780489 - Blazer™ Dx-20: 2026-01-21 Bidirectional Steerable Diagnostic Catheter
• 08714729780496 - Blazer™ Dx-20: 2026-01-21 Bidirectional Steerable Diagnostic Catheter