Sentiero Diagnostic

GUDID 04260223141454

Sentiero Diagnostic OAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Sentiero Diagnostic device with touchscreen AN100098 5. Probe EP-DP Path long AN100028-US 6. Probe EP-VIP AN100539-US 7. TEOAE Software AN100109 8. DPOAE Software AN100110 9. DPHiRES Software AN100537 10. FMDPOAE Software AN100536 11. DPOAE Threshold Estimation Software AN100111 12. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 13. Software label printer AN100414 14. Accessory box Sentiero Combo AN100261 15. Power supply Sentiero US AN101013+AN100993-USA

PATH medical GmbH

Evoked-potential audiometer
Primary Device ID04260223141454
NIH Device Record Keya4262a59-8ec0-4088-bdde-f7a4344ccfcf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentiero Diagnostic
Version Model Number100250-US4
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
GS104260223141454 [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 Diagnostic]

04260223141447Sentiero Diagnostic OAE Audiometrie Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3.
04260223141430Sentiero Diagnostic OAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cab
04260223145360Sentiero Diagnostic TEOAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
04260223141454Sentiero Diagnostic OAE Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cab

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