LATITUDE® Clarity

GUDID 00802526613838

Patient Management System

BOSTON SCIENTIFIC CORPORATION

Patient health record information system application software

• Primary Device ID: 00802526613838
• NIH Device Record Key: 5bdfca1c-110d-4b03-9be2-70fb43fa4a5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LATITUDE® Clarity
• Version Model Number: 7260
• Company DUNS: 106295384
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526613838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193473

FDA Product Code

• MXD: Recorder, event, implantable cardiac, (with arrhythmia detection)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-09
• Device Publish Date: 2020-07-01

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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• 00191506060053 - Tissue Helix: 2025-08-05 Tissue HeliX Pro
• 00191506060060 - NXT Tissue HeliX Pro: 2025-08-05 Intragastric Balloon System
• 00191506060107 - OverStitch NXT ™: 2025-08-05 Intragastric Balloon System
• 08714729144182 - Optiflo: 2025-07-17 Hemostasis Catheter
• 08714729145264 - Optiflo: 2025-07-17 Hemostasis Catheter
• 08714729874805 - LithoVue: 2025-07-08 Single-Use Digital Flexible Ureteroscope
• 08714729874812 - LithoVue: 2025-07-08 Single-Use Digital Flexible Ureteroscope