AccessGUDID - DEVICE: Sentiero Advanced NavPRO ONE (04260223143526)

GUDID

Device Identifier (DI) Information

Brand Name: Sentiero Advanced NavPRO ONE
Version or Model: 8-04-16550
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100340-BL-US1
Company Name: PATH medical GmbH

Primary DI Number: 04260223143526
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 551540334 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWJ	Stimulator, Auditory, Evoked Response
EWO	Audiometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c1f130fc-8086-433e-a62a-47e586cb815f
Public Version Date: June 30, 2022
Public Version Number: 5
DI Record Publish Date: June 01, 2018