| Primary Device ID | 03770022347144 |
| NIH Device Record Key | d7ccbfa9-0280-4a96-ae45-3eaea70797b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pen Tracker |
| Version Model Number | TALLY |
| Catalog Number | Pen Tracker |
| Company DUNS | 265572589 |
| Company Name | MODJAW |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com | |
| Phone | +33482771111 |
| support@modjaw.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03770022347144 [Primary] |
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
[03770022347144]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-03 |
| Device Publish Date | 2022-02-23 |
| 03770022347212 - Twin In Motion | 2023-03-13 A specific software solution that allows the visualisation of 3D dental models in motion |
| 03770022347250 - Tech In Motion US | 2023-02-17 The medical device Tech in Motion® includes the following parts: • A camera to detect trackers positions through infra-red em |
| 03770022347007 - Tech In Motion | 2022-03-03 The medical device Tech in Motion® includes the following parts: • A camera to detect trackers positions through infra-red em |
| 03770022347014 - Tech In Motion | 2022-03-03 The medical device Tech in Motion® includes the following parts: • A camera to detect trackers positions through infra-red em |
| 03770022347052 - NAVEX | 2022-03-03 Fiducials are the reflective targets fixed on the different trackers (pen, frontal, mandible) and should reflect infra-red light |
| 03770022347076 - Fork | 2022-03-03 Single-use support for the SMILIT mandibular tracker, which is fixed to the patient's teeth. |
| 03770022347083 - Mandibular tracker | 2022-03-03 |
| 03770022347106 - Rear band | 2022-03-03 |