Duns Number:043450879
Device Description: Neubac brand of over the counter transcutaneous electrical nerve stimulator for analgesic Neubac brand of over the counter transcutaneous electrical nerve stimulator for analgesic pain relief in the lower back.
Catalog Number
11.3000
Brand Name
Neubac
Version/Model Number
11.3000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2017
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
05223456-504c-4d3d-8906-1bd7c29d1859
Public Version Date
October 31, 2019
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
00853096004144
Quantity per Package
1
Contains DI Package
00853096004083
Package Discontinue Date
September 30, 2017
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |