← Back to catalogue

OptiMap™ System - NA

FDA UDI

Class II (US FDA UDI)

by Cortex, Inc.

Identity

Trade Name
OptiMap™ System - NA FDA UDI
Generic Name
Cardiac mapping system FDA UDI
Device Name
The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. FDA UDI
Model / Reference
FG0001-NA FDA UDI
Description
The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. FDA UDI

Identifiers

Catalog Number
OPTI-SYS-NA FDA UDI
Primary DI / UDI-DI
00850064686135 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiac mapping system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac mapping system

OptiMap™ System - NA by Cortex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac mapping system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Cortex, Inc.

Sources (1)

  • FDA UDI 0154f4d1-322d-4baa-bd24-a4f1e42413d4 34 fields · synced Jun 1, 2026