MULTI-SPEECH

GUDID 04961333230013

Multi-Speech Microphone, Dynamic

PENTAX OF AMERICA, INC.

Voice amplification system
Primary Device ID04961333230013
NIH Device Record Key0d7aa5d5-2d37-4f8f-b4ad-7bc71a160bf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMULTI-SPEECH
Version Model Number3709
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333230013 [Primary]

FDA Product Code

KLXElectroglottograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-04-06

On-Brand Devices [MULTI-SPEECH]

04961333230020Multi-Speech USB Sound Recorder & Preamp
04961333230013Multi-Speech Microphone, Dynamic
04961333230006Multi-Speech Microphone, Condensor
04961333229659Multi-Speech Microphone Preamp
04961333229642Multi-Speech Software
04961333254309Multi-Speech Microphone, Condensor

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