Sentiero Advanced

GUDID 04260223145247

Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. Headphone DD-45 AN100306 8. Probe EP-LT AN101021 9. Accessory box EP-LT AN101043 10. ABR Quick SW AN100337-Quick 11. TEOAE Quick SW AN100109-Quick 12. DPOAE Quick SW AN100110-Quick 13. FMDPOAE SW AN100536 14. Tymp Class 2 SW AN100560 15. Audio Class 4 Advanced SW AN100653 16. Mira PC Patient Management SW AN100116 17. Label Printer SW AN100414 18. Power Supply Sentiero Advanced US AN101016+AN100993-USA 19. Tympanometry add-on TY-MA AN100947 20. Accessory box Grason AN100734 21. Tympanometry cavity AN100549 22. Probe tip small PT-S AN100014-W (3 pcs.) 23. Probe tip medium PT-A AN100013 (5 pcs.)

PATH medical GmbH

Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer Evoked-potential audiometer

• Primary Device ID: 04260223145247
• NIH Device Record Key: 1e17b35c-69a9-4b2d-ae09-34258877e675
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentiero Advanced
• Version Model Number: 100340-SC-ALL-LT
• Company DUNS: 551540334
• Company Name: PATH medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260223145247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133012

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-06
• Device Publish Date: 2020-06-27

On-Brand Devices [Sentiero Advanced]

• 04260223142444: Sentiero Advanced device with touchscreen
• 04260223141621: Sentiero Advanced ABR US4 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cable
• 04260223141614: Sentiero Advanced ABR US3 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cabl
• 04260223141607: Sentiero Advanced ABR US2 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cable
• 04260223141591: Sentiero Advanced ABR US1 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cable
• 04260223143625: Sentiero Advanced ABR US0 Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data cable
• 04260223145278: Sentiero Advanced Starter Kit Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data c
• 04260223145261: 100340-SC-AT Sentiero Advanced ABR and TEOAE Screening Set Content: 1. Case AN100503 2. Inlay Se
• 04260223145254: Sentiero Advanced ABR and TEOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN1006
• 04260223145247: Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening Set Content: 1. Case AN100503 2. In
• 04260223145230: Sentiero Advanced ABR, OAE, Tympanometry and Audio Screening Set Content: 1. Case AN100503 2. In
• 04260223145223: Sentiero Advanced ABR and DPOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN1006
• 04260223145216: Sentiero Advanced ABR and DPOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN1006
• 04260223145209: Sentiero Advanced Easy Diag Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB data
• 04260223143632: Sentiero Advanced ABR Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN100677 3. USB
• 04260223146527: Sentiero Advanced ABR and DPOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN1006
• 04260223146718: Sentiero Advanced ABR and DPOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentiero AN1006
• 04260223146701: Sentiero Advanced ABR and DPOAE or TEOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentie
• 04260223146695: Sentiero Advanced ABR and DPOAE or TEOAE Screening Set Content: 1. Case AN100503 2. Inlay Sentie