Duns Number:079865289
Device Description: EARGO NEO HiFi, Accessory Kit, Tetra Flexi Palm, Size Large
Catalog Number
99-0111-001
Brand Name
EARGO
Version/Model Number
99-0111-001
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ESD
Product Code Name
Hearing aid, air conduction
Public Device Record Key
0aa14760-0c02-4818-a146-5743b3d15b90
Public Version Date
January 27, 2020
Public Version Number
1
DI Record Publish Date
January 17, 2020
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 | 9 |
2 | A medical device with a moderate to high risk that requires special controls. | 15 |