Duns Number:480002286
Device Description: ZERENA 9 B 105 FW 2.0
Catalog Number
-
Brand Name
Bernafon
Version/Model Number
187310
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
KLW
Product Code Name
Masker, tinnitus
Public Device Record Key
231af765-00cf-4a43-8fb4-bb9491458102
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 05, 2018
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 |