Duns Number:339182263
Device Description: EMG/EP System
Catalog Number
-
Brand Name
NeMus PC PERIPHERAL
Version/Model Number
B9800066800
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
K073415
Product Code
GWF
Product Code Name
Stimulator, Electrical, Evoked Response
Public Device Record Key
874ca708-3d90-4f5d-a3ca-ca192a9aed6e
Public Version Date
June 03, 2019
Public Version Number
1
DI Record Publish Date
May 24, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 67 |