AccessGUDID - DEVICE: Pen Tracker (03770022347144)

GUDID

Device Identifier (DI) Information

Brand Name: Pen Tracker
Version or Model: TALLY
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Pen Tracker
Company Name: MODJAW

Primary DI Number: 03770022347144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 265572589 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47556	Jaw physiology evaluation system	An assembly of mains electricity (AC-powered) devices designed to record parameters for mandibular and muscles of mastication function, primarily to aid in the diagnosis and treatment of temperomandibular joint (TMJ) and myofascial pain dysfunction (MPD) disorders, and for orthodontic, denture, and reconstruction patient evaluation. It typically uses surface electromyography to evaluate muscle groups at rest or in function; sonography to detect sounds/vibrations from the TMJ joint and/or other computer-based system to non-invasively track the mandible in function or identify its position in space relative to the skull.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFS	Device, Jaw Tracking, For Monitoring Jaw Positions

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

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