Duns Number:957536014
Device Description: Ulnar Elbow Biosensor Kit (Left) Case - Comprised of NC-S72 and NC-S74 DI Numbers 00851221 Ulnar Elbow Biosensor Kit (Left) Case - Comprised of NC-S72 and NC-S74 DI Numbers 00851221006162 & 00851221006186. There are 6 electrodes in the kit.
Catalog Number
-
Brand Name
ADVANCE
Version/Model Number
NC-S76
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
Yes
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
K000565
Product Code
JXE
Product Code Name
Device, Nerve Conduction Velocity Measurement
Public Device Record Key
31ef5cd1-10ec-4aad-a824-dc4e11f1997d
Public Version Date
October 22, 2018
Public Version Number
4
DI Record Publish Date
September 07, 2016
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. | 31 |