VISITAG SURPOINT External Processing Unit D160801

GUDID 10846835017885

External Processing Unit

Biosense Webster Inc

Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer Cardiac mapping system computer 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

• 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
• 10846835025828 - OPTRELL Mapping Catheter with TRUEref Technology: 2023-10-12 OPTRELL-36 D-F Curve
• 10846835017427 - TX eco Cable: 2023-07-31 TX eco Cable Kit
• 10846835017434 - TX eco Cable Dongle Spare Part: 2023-07-31 TX eco Cable Dongle Spare Part
• 10846835020229 - LASSOSTAR Non-NAV -Circular navigation catheter: 2023-07-27 2.44FR LASSOSTAR non-NAV,10P,20MM
• 10846835020236 - LASSOSTAR Non-NAV -Circular navigation catheter: 2023-07-27 2.44FR LASSOSTAR non-NAV,10P,15MM
• 10846835020243 - LASSOSTAR Non-NAV -Circular navigation catheter: 2023-07-27 2.44FR LASSOSTAR non-NAV,10P,25MM