Duns Number:201252087
Device Description: Vista 900 Rm 312 (pewter)
Catalog Number
050-5861-P744
Brand Name
Unitron
Version/Model Number
050-5861-P744
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)
-
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
6c144506-fb74-4135-92fe-1c35d8a661bd
Public Version Date
October 06, 2020
Public Version Number
3
DI Record Publish Date
September 12, 2016
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 | 293 |
2 | A medical device with a moderate to high risk that requires special controls. | 1875 |