ELECTROGLOTTOGRAPH

GUDID 04961333229888

KayPentax Electroglottograph

PENTAX OF AMERICA, INC.

Electroglottograph
Primary Device ID04961333229888
NIH Device Record Key808d5a9b-8904-4534-b3fd-5e1bfa407bea
Commercial Distribution StatusIn Commercial Distribution
Brand NameELECTROGLOTTOGRAPH
Version Model Number6103
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *10-40 degrees Celsius, 30-90% humidity, 700-1060 millibars air pressure

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333229888 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLXElectroglottograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-06

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