Duns Number:265572589
Device Description: The pen is used in order to collect positioning of reference points in space.The pen is us The pen is used in order to collect positioning of reference points in space.The pen is used to calibrate the precision of the device.
Catalog Number
Pen Tracker
Brand Name
Pen Tracker
Version/Model Number
TALLY
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
-
Product Code
NFS
Product Code Name
Device, Jaw Tracking, For Monitoring Jaw Positions
Public Device Record Key
d7ccbfa9-0280-4a96-ae45-3eaea70797b4
Public Version Date
March 03, 2022
Public Version Number
1
DI Record Publish Date
February 23, 2022
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 | 9 |