PRC 19285-2

GUDID 00816486021060

Quasselkiste App

PRENTKE ROMICH COMPANY

Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer Voice synthesizer/digitizer
Primary Device ID00816486021060
NIH Device Record Keycab17c09-19d8-42dc-8493-999e4370f6bb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRC
Version Model NumberQuasselkiste App
Catalog Number19285-2
Company DUNS080143399
Company NamePRENTKE ROMICH COMPANY
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com
Phone800-262-1984
Emailservice@prc-saltillo.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816486021060 [Primary]

FDA Product Code

ILQSystem, Communication, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-16
Device Publish Date2023-11-08

On-Brand Devices [PRC]

00858526006729Via™ Pro 84 Location TouchGuide for WFL
00816486021084LAMP Words For Life (US) App
00816486021077LAMP Words For Life (UK) App
00816486021060Quasselkiste App

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.