Cadwell Guardian

FDA UDI

Class II (US FDA UDI)

by Cadwell Industries, Inc.

Identity

Trade Name: Cadwell Guardian FDA UDI
Generic Name: Neurophysiologic monitoring system FDA UDI
Device Name: Input Extender Pod, Amplifier FDA UDI
Model / Reference: 199332-000 FDA UDI
Description: Input Extender Pod, Amplifier FDA UDI

Identifiers

Primary DI / UDI-DI: 00840067103517 FDA UDI
FDA Product Code: ETN FDA UDI
PDQ FDA UDI
GWQ FDA UDI
GWJ FDA UDI
IKN FDA UDI
OLT FDA UDI
GZO FDA UDI
GWF FDA UDI
JXE FDA UDI
GWE FDA UDI
GMDN Term: Neurophysiologic monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 874.1820 FDA UDI
882.1400 FDA UDI
882.1900 FDA UDI
890.1375 FDA UDI
882.1540 FDA UDI
882.1870 FDA UDI
882.1550 FDA UDI
882.1890 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Neurophysiologic monitoring system

Cadwell Guardian 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 6e58e53f-3fea-47a5-a131-047eafeb4705 34 fields · synced Jun 9, 2026