Maestro 4000™ Remote Control M0044020R0

GUDID 08714729862093

RF Cardiac Ablation Remote Control

BOSTON SCIENTIFIC CORPORATION

Percutaneous radio-frequency ablation system generator

• Primary Device ID: 08714729862093
• NIH Device Record Key: bd1635e9-5c4d-48de-9cff-9ae32dc424c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maestro 4000™ Remote Control
• Version Model Number: M0044020R0
• Catalog Number: M0044020R0
• 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	08714729862093 [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: 2015-01-27

On-Brand Devices [Maestro 4000™ Remote Control]

• 08714729862093: RF Cardiac Ablation Remote Control
• 08714729862062: RF Cardiac Ablation Remote Control