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Cadwell Guardian
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 199335-000-008Model Neuro Accessory
Identity
- Trade Name
- Cadwell Guardian EUDAMEDFDA UDI
- Generic Name
- Neurophysiologic monitoring system FDA UDI
- Device Name
- TCS Pod Cable, 8 meter FDA UDI
- Model / Reference
- 199335-000-008 EUDAMEDFDA UDINeuro Accessory EUDAMED
- Description
- TCS Pod Cable, 8 meter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840067103562 EUDAMEDFDA UDI
- Basic UDI-DI
- 08400671NeuroAccessoryQX EUDAMED
- FDA Product Code
- GWF FDA UDIGWQ FDA UDIPDQ FDA UDIETN FDA UDIGZO FDA UDIJXE FDA UDIOLT FDA UDIGWJ FDA UDIIKN FDA UDIGWE FDA UDI
- EMDN Code
- Z121002 NERVOUS SYSTEM MONITORING SYSTEMS EUDAMED
- GMDN Term
- Neurophysiologic monitoring system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 882.1870 FDA UDI882.1400 FDA UDI874.1820 FDA UDI882.1540 FDA UDI882.1550 FDA UDI882.1900 FDA UDI890.1375 FDA UDI882.1890 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Neurophysiologic monitoring system
Cadwell Guardian by Cadwell Industries, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cadwell Industries, Inc.
Sources (2)
- FDA UDI 0a482ab6-3802-4ed4-9082-f9c388ca92b1 34 fields · synced Oct 5, 2026
- EUDAMED a217ff22-661b-4a8f-859c-7fd4a0f12be7 61 fields · synced Oct 5, 2026