Sentiero Desktop

GUDID 04260223142468

Sentiero Desktop (Tymp Diagnostic)

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223142468
NIH Device Record Key52099951-599f-4e48-b3c8-9be1628f0627
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentiero Desktop
Version Model Number100434-DG
Company DUNS551540334
Company NamePATH medical GmbH
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 Datetrue
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
GS104260223142468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETYTester, Auditory Impedance

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 Date2016-08-31

On-Brand Devices [Sentiero Desktop]

04260223142468Sentiero Desktop (Tymp Diagnostic)
04260223142451Sentiero Desktop (Tymp Screening)

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