Sentiero Screening2

GUDID 04260223145131

Sentiero Screening2 Audio and DPOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Screening2 device with touchscreen AN100098-S2 5. Headphone DD-45 AN100306 6. Probe EP-LT AN101021 7. Audio Class4 Advanced Software AN100653 8. DPOAE Quick Software AN100110-Quick 9. FMDPOAE Software AN100536 10. Software label printer AN100414 11. Accessory box EP-LT AN101043 12. Power supply Sentiero US AN101013+AN100993-USA

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223145131
NIH Device Record Key374c9058-b750-4ce4-bfeb-dbac9aa95d83
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentiero Screening2
Version Model Number100250-SC-AuD-LT
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 Kittrue
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
GS104260223145131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EWOAudiometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-06
Device Publish Date2020-06-27

On-Brand Devices [Sentiero Screening2]

04260223145193Sentiero Screening2 TEOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
04260223145186Sentiero Screening2 TEOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
04260223145179Sentiero Screening2 DPOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
04260223145162Sentiero Screening2 DPOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
04260223145155Sentiero Screening2 Audio and TEOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3.
04260223145148Sentiero Screening2 Audio and TEOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3.
04260223145131Sentiero Screening2 Audio and DPOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3.
04260223145124Sentiero Screening2 Audio and DPOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3.

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