Identity
- Trade Name
- OptiMap™ Fiber Optic Cable FDA UDI
- Generic Name
- Sensor catheter fibreoptic connection cable FDA UDI
- Device Name
- OptiMap™ Fiber Optic Cable FDA UDI
- Model / Reference
- OPTI-FOC FDA UDI
- Description
- OptiMap™ Fiber Optic Cable FDA UDI
Identifiers
- Catalog Number
- FG0006 FDA UDI
- Primary DI / UDI-DI
- 00850064686104 FDA UDI
- FDA Product Code
- IKD FDA UDI
- GMDN Term
- Sensor catheter fibreoptic connection cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1175 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sensor catheter fibreoptic connection cable
OptiMap™ Fiber Optic Cable by Cortex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sensor catheter fibreoptic connection cable.
- Cable LWL — RAUMEDIC AG · 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 b7bd59d9-c412-47bf-98d0-ab6d982915b3 34 fields · synced Jun 8, 2026