MICROPHONE ASSAY KIT

GUDID 04961333255979

6651 MICROPHONE ASSAY KIT(MU0P00000956)(Accessory for PAS 6600)

PENTAX OF AMERICA, INC.

Speech assistive training device
Primary Device ID04961333255979
NIH Device Record Key88f73aa5-a56a-4526-b2ec-2c6556ba5c17
Commercial Distribution StatusIn Commercial Distribution
Brand NameMICROPHONE ASSAY KIT
Version Model Number6651
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333255979 [Primary]

FDA Product Code

KLXElectroglottograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-07-29
Device Publish Date2025-07-21

Devices Manufactured by PENTAX OF AMERICA, INC.

04961333255979 - MICROPHONE ASSAY KIT2025-07-29 6651 MICROPHONE ASSAY KIT(MU0P00000956)(Accessory for PAS 6600)
04961333255979 - MICROPHONE ASSAY KIT2025-07-29 6651 MICROPHONE ASSAY KIT(MU0P00000956)(Accessory for PAS 6600)
04961333255986 - Disposables Kit2025-07-29 6650 Disposables Kit (MU0P00001081)(Accessory for PAS 6600)
04961333255016 - LARYNGOSTROBOSCOPE2025-05-05 LARYNGEAL STROBE 9500
04961333255702 - LARYNGOSTROBOSCOPE2025-05-05 9500LX, Laryngeal Microphone "Accessory for 9500"
04961333255719 - LARYNGOSTROBOSCOPE2025-05-05 9500MC, Lapel Microphone "Accessory for 9500"
04961333255726 - LARYNGOSTROBOSCOPE2025-05-05 9500FS, Footswitch "Accessory for 9500 "
00854924006255 - C2 CryoBalloon Ablation System 2025-04-14 Gen 2 360 Degree Pear Catheter
00854924006293 - C2 CryoBalloon Ablation System2025-04-14 Gen 2 360 Degree Standard Catheter

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