Duns Number:551540334
Device Description: Sentiero NavPRO ONE Set:Content:1. Sentiero Advance device AN100360-NPO2. Carrying case AN Sentiero NavPRO ONE Set:Content:1. Sentiero Advance device AN100360-NPO2. Carrying case AN1009283. Inlay AN1006774. Insert Earphone PIEP Bio-Logic AN100860-BL5. Bone Conductor B81 AN100888 or B71W AN100344 optionally6. Electrode Trunk Cable AN1008817. Electrode Lead Cable AN100891-18. Electrodes AN1004689. ABR Software AN10033710. ABR Binaural Software AN10042411. ABR FFC Software AN10046612. ECochG Software AN10046413. Software label printer AN10041414. PC Patient Management Software AN10011615. USB data cable AN10008916. USB stick Bio-Logic AN100724-BL17. Power supply Sentiero Advanced US AN100268-US18. Manual Bio-Logic AN100904-EN-BL
Catalog Number
100340-BL-US1
Brand Name
Sentiero Advanced NavPRO ONE
Version/Model Number
8-04-16550
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EWO
Product Code Name
Audiometer
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 152 |