Identity
- Trade Name
- Pen Tracker FDA UDI
- Generic Name
- Jaw physiology evaluation system FDA UDI
- Device Name
- Mandibular tracker EUDAMEDThe pen is used in order to collect positioning of reference points in space. The pen is used to calibrate the precision of the device. FDA UDI
- Model / Reference
- TALLY EUDAMEDFDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- Pen Tracker FDA UDI
- Primary DI / UDI-DI
- 03770022347144 EUDAMEDFDA UDI
- Basic UDI-DI
- 3770022347KITREU5V EUDAMED
- Direct Marketing DI
- 03770022347144 EUDAMED
- FDA Product Code
- NFS FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Jaw physiology evaluation system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.2060 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mandibular tracker by Modjaw — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 3770022347KITREU5V | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ModJaw
- EUDAMED SRN
- FR-MF-000009804
Sources (2)
- EUDAMED f8cfd9d8-9f24-4ada-b327-513741e690ff 61 fields · synced Jun 18, 2026
- FDA UDI d7ccbfa9-0280-4a96-ae45-3eaea70797b4 35 fields · synced May 30, 2026