Duns Number:480662550
Device Description: Relate3.1 Gold RIC 312 (sand)
Catalog Number
050-6403-R876
Brand Name
Relate3.1 Gold RIC 312
Version/Model Number
050-6403-R876
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
-
Product Code
OSM
Product Code Name
Hearing Aid, Air Conduction With Wireless Technology
Public Device Record Key
3ae079d8-e655-4186-a919-a2c84915c3a9
Public Version Date
July 29, 2022
Public Version Number
1
DI Record Publish Date
July 21, 2022
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 | 103 |
2 | A medical device with a moderate to high risk that requires special controls. | 2466 |