Duns Number:112117283
Device Description: 2 pairs of Aleve Direct Therapy TENs Device Refill Gel Pads packaged in one re-sealable p 2 pairs of Aleve Direct Therapy TENs Device Refill Gel Pads packaged in one re-sealable pouch.
Catalog Number
-
Brand Name
Aleve
Version/Model Number
1613579
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 26, 2019
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
98aaee1b-904b-4407-9b03-0c3b4a1368d7
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
10325866564945
Quantity per Package
6
Contains DI Package
00325866564948
Package Discontinue Date
-
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |