Sentiero Advanced NavPRO ONE

Basic Information

• Brand Name: Sentiero Advanced NavPRO ONE
• Primary DI: 04260223143526
• Version / Model: 8-04-16550
• Catalog Number: 100340-BL-US1
• Company Name: PATH medical GmbH
• Labeler DUNS: 551540334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-01
• Public Version: 5
• Public Version Date: 2022-06-30
• Public Version Status: Update
• Public Device Record Key: c1f130fc-8086-433e-a62a-47e586cb815f

Device Description

Sentiero NavPRO ONE Set: Content: 1. Sentiero Advance device AN100360-NPO 2. Carrying case AN100928 3. Inlay AN100677 4. Insert Earphone PIEP Bio-Logic AN100860-BL 5. Bone Conductor B81 AN100888 or B71W AN100344 optionally 6. Electrode Trunk Cable AN100881 7. Electrode Lead Cable AN100891-1 8. Electrodes AN100468 9. ABR Software AN100337 10. ABR Binaural Software AN100424 11. ABR FFC Software AN100466 12. ECochG Software AN100464 13. Software label printer AN100414 14. PC Patient Management Software AN100116 15. USB data cable AN100089 16. USB stick Bio-Logic AN100724-BL 17. Power supply Sentiero Advanced US AN100268-US 18. Manual Bio-Logic AN100904-EN-BL

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWJ	Stimulator, Auditory, Evoked Response	Neurology	882.1900	2
EWO	Audiometer	Ear, Nose, Throat	874.1050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35747	Evoked-potential audiometer	An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260223143526	GS1