OPAL HDx™ M004OPLINSTALL2EN0

GUDID 00191506055370

Mapping System

BOSTON SCIENTIFIC CORPORATION

Cardiac mapping system

• Primary Device ID: 00191506055370
• NIH Device Record Key: 2394ca1c-7ed4-48af-a536-3520b480956c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPAL HDx™
• Version Model Number: M004OPLINSTALL2EN0
• Catalog Number: M004OPLINSTALL2EN0
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00191506055370 [Primary]

FDA Product Code

• DQK: Computer, diagnostic, programmable

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: 2024-10-16
• Device Publish Date: 2024-10-08

On-Brand Devices [OPAL HDx™]

• 00191506055370: Mapping System
• 00191506055325: Mapping System Signal Station
• 00191506055301: Mapping System Workstation PC