OptiMap™ Catheter - 60mm OPTI-CATH-60

GUDID 00850064686074

The OptiMap™ Catheter is a basket catheter used to detect electrical potentials from the endocardial surfaces of the heart

Cortex, Inc.

Cardiac mapping catheter, percutaneous, single-use

• Primary Device ID: 00850064686074
• NIH Device Record Key: ac89828b-1c46-470d-8041-d69e48c4f922
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptiMap™ Catheter - 60mm
• Version Model Number: FG0003-60
• Catalog Number: OPTI-CATH-60
• Company DUNS: 119228234
• Company Name: Cortex, 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: true
• 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	00850064686074 [Primary]

FDA Product Code

• MTD: Catheter, Intracardiac Mapping, High-Density Array

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-18
• Device Publish Date: 2025-07-10