Duns Number:080294073
Device Description: Reletex from Reliefband is a prescription device that is applied to the underside of the w
Catalog Number
PCN3
Brand Name
Reletex
Version/Model Number
PCN3
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
Yes
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
K994387,K994387,K994387
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
dc4ec6d2-94cb-4e4e-a58d-ee702a65b2e4
Public Version Date
July 07, 2021
Public Version Number
1
DI Record Publish Date
June 29, 2021
Package DI Number
20661168300018
Quantity per Package
6
Contains DI Package
00661168300014
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 |