Identity
- Trade Name
- GCX FDA UDI
- Generic Name
- Instrument trolley FDA UDI
- Device Name
- CART FOR EEG-9200 / EEG-1200 FDA UDI
- Model / Reference
- A/SONYCART-3 FDA UDI
- Description
- CART FOR EEG-9200 / EEG-1200 FDA UDI
Identifiers
- Catalog Number
- A/SONYCART-3 FDA UDI
- Primary DI / UDI-DI
- 00841983103766 FDA UDI
- FDA Product Code
- OLT FDA UDI
- GMDN Term
- Instrument trolley FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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: Instrument trolley
Gcx by Nihon Kohden America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument trolley.
- AtriCure System Cart — ATRICURE, INC. · Class I
- Nihon Kohden, EEG-1200A Series Neurofax — Nihon Kohden Corp. · Class II
- ADVANCED TROLLEY — ADVANCED INSTRUMENTATIONS, INC. · Class I
- AtriCure System Cart — ATRICURE, INC. · Class I
- AtriCure System Cart — ATRICURE, INC. · Class I
- AtriCure System Cart — ATRICURE, INC. · Class I
- Nihon Kohden, EEG-1200A Series Neurofax — Nihon Kohden Corp. · Class II
- AtriCure System Cart — ATRICURE, 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
- Nihon Kohden America, Inc.
Sources (1)
- FDA UDI 9650ae1d-1850-496d-bc2d-dd2450ad35f9 35 fields · synced May 30, 2026