Duns Number:559784736
Device Description: Retention device to hold Baha 5 SuperPower sound processor in Under-the-Ear position (UTE)
Catalog Number
P1173608
Brand Name
Baha 5 SuperPower Earhook 2+ (L)
Version/Model Number
P1173608
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
K153245
Product Code
LXB
Product Code Name
Hearing aid, bone conduction
Public Device Record Key
78c4d19d-40c7-4c95-afc2-041043025749
Public Version Date
October 13, 2021
Public Version Number
3
DI Record Publish Date
February 26, 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 | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 276 |