Identity
- Trade Name
- Cascade FDA UDI
- Generic Name
- Neurophysiologic monitoring system FDA UDI
- Device Name
- Cascade TCS-1000 FDA UDI
- Model / Reference
- 190258-200 FDA UDI
- Description
- Cascade TCS-1000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067100196 FDA UDI
- FDA Product Code
- GWQ FDA UDIGWE FDA UDIOLV FDA UDIIKN FDA UDIOLT FDA UDIGWF FDA UDIJXE FDA UDIGWJ FDA UDI
- GMDN Term
- Neurophysiologic monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 FDA UDI882.1890 FDA UDI890.1375 FDA UDI882.1870 FDA UDI882.1550 FDA UDI882.1900 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
No
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
No
FDA UDI
Category: Neurophysiologic monitoring system
Cascade by Cadwell Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Neurophysiologic monitoring system.
- Guidance — Nuvasive, Inc. · Class II
- Arcus — ALPHATEC SPINE, INC. · Class II
- SafeOp 3 — ALPHATEC SPINE, INC. · Class II
- Neuromaster — Nihon Kohden Corp. · Class II
- NVM5 — Nuvasive, Inc. · Class II
- SafeOp — ALPHATEC SPINE, INC. · Class II
- BIS — Covidien LP · Class II
- Resident Expert Software Module — FHC, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cadwell Industries, Inc.
Sources (1)
- FDA UDI b4368379-e663-4da7-b37c-e0ad179d5205 34 fields · synced Jun 9, 2026