Duns Number:116956807
Catalog Number
KMICP
Brand Name
Micro Plus
Version/Model Number
Micro Plus
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
K915210,K915210
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
a37e2bf1-3356-46ad-a33c-0268df6c93fc
Public Version Date
October 23, 2019
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
10857771003160
Quantity per Package
60
Contains DI Package
00857771003163
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 80 |