Celsius D7BTCE5L252RT

GUDID 10846835005226

Biosense Webster Inc

Cardiac radio-frequency ablation system catheter

• Primary Device ID: 10846835005226
• NIH Device Record Key: 2e7065ed-e092-435c-9622-dbd9fbb9d23e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celsius
• Version Model Number: D7BTCE5L252RT
• Catalog Number: D7BTCE5L252RT
• 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: true
• 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	10846835005226 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950005

FDA Product Code

• LPB: Cardiac ablation percutaneous catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-02-10
• Device Publish Date: 2016-09-15

Devices Manufactured by Biosense Webster Inc

• 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
• 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