Trigno Maize Sensor

FDA UDI

Class II (US FDA UDI)

by Delsys, Inc.

Identity

Trade Name: Trigno Maize Sensor FDA UDI
Generic Name: Psychophysiological biofeedback system FDA UDI
Device Name: Trigno Wireless Biofeedback System component. FDA UDI
Model / Reference: SP-W06-029 FDA UDI
Description: Trigno Wireless Biofeedback System component. FDA UDI

Identifiers

Primary DI / UDI-DI: 00851679007353 FDA UDI
FDA Product Code: HCC FDA UDI
GMDN Term: Psychophysiological biofeedback system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5050 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Psychophysiological biofeedback system

Trigno Maize Sensor by Delsys, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Delsys, Inc.

Sources (1)

FDA UDI 9269da24-bade-49a9-b750-3495e48a7b34 33 fields · synced May 29, 2026