INTELLANAV STABLEPOINT™ M004RFSDS9620K20

GUDID 08714729992240

Ablation Catheter

BOSTON SCIENTIFIC CORPORATION

Cardiac radio-frequency ablation system catheter

• Primary Device ID: 08714729992240
• NIH Device Record Key: 1f161122-5db8-4f3c-86b1-1e1364f08828
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INTELLANAV STABLEPOINT™
• Version Model Number: M004RFSDS9620K20
• Catalog Number: M004RFSDS9620K20
• 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: true
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08714729992240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150005

FDA Product Code

• OAE: Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-08
• Device Publish Date: 2024-02-29

On-Brand Devices [INTELLANAV STABLEPOINT™]

• 08714729992240: Ablation Catheter
• 08714729992233: Ablation Catheter