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Touch Chat

FDA UDI

Class II (US FDA UDI)

by Prentke Romich Company

Identity

Trade Name
Touch Chat FDA UDI
Generic Name
Voice synthesizer/digitizer FDA UDI
Device Name
Set of 5 keyguards for Touch Chat 8.2 - 15 Location, 24 Location, 30 Location, 42 Location, 48 Location & 40 Location for WordPower 80 file FDA UDI
Model / Reference
TC8.2-KIT-KG FDA UDI
Description
Set of 5 keyguards for Touch Chat 8.2 - 15 Location, 24 Location, 30 Location, 42 Location, 48 Location & 40 Location for WordPower 80 file FDA UDI

Identifiers

Primary DI / UDI-DI
00816486020667 FDA UDI
FDA Product Code
ILQ FDA UDI
GMDN Term
Voice synthesizer/digitizer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.3710 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

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Voice synthesizer/digitizer

Touch Chat by Prentke Romich Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Voice synthesizer/digitizer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Prentke Romich Company

Sources (1)

  • FDA UDI 3d30158b-5ea3-453c-9f1c-756395f70ec9 34 fields · synced May 30, 2026