Duns Number:480002286
Device Description: CZ1 MNR, 2.4G NFM SABE DEMO CORAL 1 GPL
Catalog Number
-
Brand Name
Bernafon
Version/Model Number
216545
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OSM
Product Code Name
Hearing aid, air conduction with wireless technology
Public Device Record Key
ef334e6f-fa5a-459d-a9ab-671e6111234a
Public Version Date
October 27, 2020
Public Version Number
1
DI Record Publish Date
October 19, 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 | 198 |
2 | A medical device with a moderate to high risk that requires special controls. | 1529 |