Duns Number:079865289
Device Description: EARGO NEO ACCESSORY KIT, FLEXI PALM, SIZE SMALL
Catalog Number
99-0113-001
Brand Name
EARGO
Version/Model Number
99-0113-001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 21, 2022
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
f7170f2b-9d6e-46be-a33e-26a28f1e5a50
Public Version Date
September 22, 2022
Public Version Number
2
DI Record Publish Date
March 27, 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 |