Identity
- Trade Name
- OptiMap™ Workstation FDA UDI
- Generic Name
- Cardiac mapping system FDA UDI
- Device Name
- OptiMap Workstation FDA UDI
- Model / Reference
- FG0008 FDA UDI
- Description
- OptiMap Workstation FDA UDI
Identifiers
- Catalog Number
- OPTI-WS FDA UDI
- Primary DI / UDI-DI
- 00850064686012 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™ Workstation by Cortex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiac mapping system.
- Rhythmia™ Mapping System — Boston Scientific · Class II
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- MediGuide™ — ST. JUDE MEDICAL, INC. · Class II
- EnSite™ — ST. JUDE MEDICAL, INC. · Class II
- MediGuide™ — ST. JUDE MEDICAL, INC. · Class II
- Rhythmia™ Mapping System — Boston Scientific · Class II
- MediGuide™ — ST. JUDE MEDICAL, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cortex, Inc.
Sources (1)
- FDA UDI 6338bce9-45b6-47a0-9d0b-5bf4ae5b5c42 34 fields · synced May 30, 2026