VISITAG SURPOINT External Processing Unit D160801

GUDID 10846835017885

External Processing Unit

Biosense Webster Inc

Cardiac mapping system computer

• Primary Device ID: 10846835017885
• NIH Device Record Key: c26526db-d426-4e7f-9062-600f60bae117
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISITAG SURPOINT External Processing Unit
• Version Model Number: D160801
• Catalog Number: D160801
• Company DUNS: 020163218
• Company Name: Biosense Webster Inc
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846835017885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030031

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: 2
• Public Version Date: 2022-02-10
• Device Publish Date: 2018-07-18

Devices Manufactured by Biosense Webster Inc

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• 10846835010121 - Sterile Interface Cable: 2024-12-19 Cath to Generator CBL Sterile
• 10846835025248 - TRUPULSE™ Generator: 2024-12-19 TRUPULSE Generator
• 10846835025460 - VARIPULSE™ Bi-Directional Catheter: 2024-12-19 8.5 FR VARIPULSE™ Bi-Directional Catheter
• 10846835022780 - SOUNDSTAR CRYSTAL Ultrasound Catheter: 2024-07-04 SOUNDSTAR CRYSTAL Ultrasound Catheter
• 10846835016796 - TX eco EXT Cable: 2023-10-12 TX eco EXT Cable
• 10846835025811 - OPTRELL Mapping Catheter with TRUEref Technology: 2023-10-12 OPTRELL-36 F-J Curve