Identity
- Trade Name
- OptiMap Cart FDA UDI
- Generic Name
- Electromechanical device/system transport trolley FDA UDI
- Device Name
- OptiMap Cart FDA UDI
- Model / Reference
- FG0010 FDA UDI
- Description
- OptiMap Cart FDA UDI
Identifiers
- Catalog Number
- OPTI-CART FDA UDI
- Primary DI / UDI-DI
- 00850064686036 FDA UDI
- FDA Product Code
- DQK FDA UDI
- GMDN Term
- Electromechanical device/system transport trolley 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electromechanical device/system transport trolley
OptiMap Cart by Cortex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electromechanical device/system transport trolley.
- ITD — TOUCHPOINT MEDICAL, Inc. · Class I
- seca 403 — Seca Corp. · Class I
- ITD — TOUCHPOINT MEDICAL, Inc. · Class I
- ITD — TOUCHPOINT MEDICAL, Inc. · Class I
- MULTIX SOLUTIONS SRL — MULTIX SOLUTIONS SRL · Class I
- ITD — TOUCHPOINT MEDICAL, Inc. · Class I
- Emprint SX — Covidien LP · Class II
- ITD — TOUCHPOINT MEDICAL, Inc. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cortex, Inc.
Sources (1)
- FDA UDI 1ace23b1-0e8b-4551-af40-4cce85ad3493 34 fields · synced May 30, 2026