Duns Number:105714027
Device Description: A reusable electrical cable that connects the TwitchView™ monitor to the single-use electr A reusable electrical cable that connects the TwitchView™ monitor to the single-use electrode array.
Catalog Number
-
Brand Name
TwitchView™
Version/Model Number
Cable Assembly v1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172843
Product Code
KOI
Product Code Name
Stimulator, Nerve, Peripheral, Electric
Public Device Record Key
eb29afaf-0170-463d-b915-76574f3c565e
Public Version Date
October 08, 2018
Public Version Number
1
DI Record Publish Date
September 05, 2018
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. | 5 |