Duns Number:157412271
Device Description: Audio Service S_ITE CROS QUIX G5 L BLK TBLU Hearing Aid
Catalog Number
10960049
Brand Name
Audio Service
Version/Model Number
S_ITE CROS QUIX G5 L BLK TBLU
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 18, 2020
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
ESD
Product Code Name
Hearing Aid, Air Conduction
Public Device Record Key
698427c1-0416-4447-b9f7-796bcdc5e7f5
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
April 13, 2019
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 | 1885 |
2 | A medical device with a moderate to high risk that requires special controls. | 5568 |