Duns Number:539177681
Device Description: These hearing aids are for users age 18 and older to compensate for perceived mild-to-mode These hearing aids are for users age 18 and older to compensate for perceived mild-to-moderate hearing impairment.
Catalog Number
-
Brand Name
Go Hearing
Version/Model Number
Go Prime (C600)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
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
68b29b3b-2ab8-43e0-b912-64ef79f0be46
Public Version Date
April 21, 2022
Public Version Number
1
DI Record Publish Date
April 13, 2022
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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 8 |