Maestro 3000™ M00421000TCR0

GUDID 08714729811923

RF Cardiac Ablation Controller Refurbished

BOSTON SCIENTIFIC CORPORATION

Percutaneous radio-frequency ablation system generator

• Primary Device ID: 08714729811923
• NIH Device Record Key: 2b7d7a2d-dce3-42e7-8e3b-019d2d5b78d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maestro 3000™
• Version Model Number: M00421000TCR0
• Catalog Number: M00421000TCR0
• 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: true
• 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	08714729811923 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P020025

FDA Product Code

• OAD: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-06-10
• Device Publish Date: 2014-11-11

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 08714729838005 - Capio SLIM: 2024-11-13 Suture Capturing Device
• 00191506043193 - FARAWAVE™ NAV: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043209 - FARAWAVE™ NAV: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043216 - FARAWAVE™: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043223 - FARAWAVE™: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043698 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator
• 00191506043704 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator
• 00191506043711 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator