Catalog Number

Frontal Tracker

Brand Name

Frontal Tracker

Version/Model Number

TIARA

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

e6dd51ba-ce89-4703-a23f-f021b4df67c3

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

-