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PRiO 84 Location Keyguard

FDA UDI

Class II (US FDA UDI)

by Prentke Romich Company

Identity

Trade Name
PRiO 84 Location Keyguard FDA UDI
Generic Name
Voice synthesizer/digitizer FDA UDI
Device Name
This keyguard specifically designed to work with 84 LAMP WFL vocabulary files on the PRiO. FDA UDI
Model / Reference
17281 FDA UDI
Description
This keyguard specifically designed to work with 84 LAMP WFL vocabulary files on the PRiO. FDA UDI

Identifiers

Primary DI / UDI-DI
00858526006583 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

No

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

PRiO 84 Location Keyguard 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 2183c0c1-b3ee-4508-b24e-7ee825e44a33 34 fields · synced Jun 8, 2026