Maestro 3000® RF Cardiac Ablation Pod 100 M00421860TR0

GUDID 08714729821755

RF Cardiac Ablation Pod 100

BOSTON SCIENTIFIC CORPORATION

Percutaneous radio-frequency ablation system generator

• Primary Device ID: 08714729821755
• NIH Device Record Key: db84788b-483f-4db1-af23-76c424c04f27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maestro 3000® RF Cardiac Ablation Pod 100
• Version Model Number: M00421860TR0
• Catalog Number: M00421860TR0
• 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: false
• 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	08714729821755 [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: 2015-10-14

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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• 00191506046354 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046361 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046378 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046385 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter