Duns Number:116956807
Catalog Number
KBSNMS2
Brand Name
BioStim NMS 2
Version/Model Number
NMS 2
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
K031427,K031427
Product Code
IPF
Product Code Name
Stimulator, Muscle, Powered
Public Device Record Key
5cf06b62-769d-4bf7-8861-76dec84ead23
Public Version Date
February 19, 2021
Public Version Number
8
DI Record Publish Date
September 23, 2016
Package DI Number
10857771003207
Quantity per Package
48
Contains DI Package
00857771003200
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 |