Duns Number:178180246
Device Description: T-Scan Windows Software, 1 Novus Handpiece (USB Connection), 20 Large & 20 Small Sensors, T-Scan Windows Software, 1 Novus Handpiece (USB Connection), 20 Large & 20 Small Sensors, 2 Large & 2 Small Sensor Supports, 1 Novus Handpiece Holder, 3 Adhesive Strips, 90 Day Free Customer Support, One Year Parts & Labor Warranty, Interactive Help File, Electronic Operations Manual.
Catalog Number
DN1
Brand Name
T-Scan Novus
Version/Model Number
T-Scan System
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Product Code
EFH
Product Code Name
Paper, Articulation
Public Device Record Key
74b392cf-59e7-487a-94b7-a7427c86966d
Public Version Date
November 11, 2020
Public Version Number
1
DI Record Publish Date
November 03, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 199 |