Duns Number:080294073
Device Description: Reliefband® Premier Slate Blue is a rechargeable, digital wearable device that is worn on
Catalog Number
2.0
Brand Name
Reliefband® Premier Slate Blue
Version/Model Number
2.0 Slate Blue
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
8219621b-952b-4b73-99ab-904336d74c05
Public Version Date
July 07, 2021
Public Version Number
1
DI Record Publish Date
June 29, 2021
Package DI Number
30661168600030
Quantity per Package
6
Contains DI Package
00661168600039
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |