Identity
- Trade Name
- KIT PATIENT FDA UDI
- Generic Name
- Jaw physiology evaluation system FDA UDI
- Device Name
- A set of trackers intended to be placed on the patient’s head and in patient’s mouth including : - Mandibular tracker - Frontal tracker - pen tracker FDA UDI
- Model / Reference
- KIT FDA UDI
- Description
- A set of trackers intended to be placed on the patient’s head and in patient’s mouth including : - Mandibular tracker - Frontal tracker - pen tracker FDA UDI
Identifiers
- Catalog Number
- KIT FDA UDI
- Primary DI / UDI-DI
- 03770022347229 FDA UDI
- FDA Product Code
- NFS FDA UDI
- GMDN Term
- Jaw physiology evaluation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.2060 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Category: Jaw physiology evaluation system
Kit Patient by Modjaw — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- M-Scan — BIO-RESEARCH ASSOCIATES, INC. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Modjaw
Sources (1)
- FDA UDI a37f59b2-086d-4160-a0e6-1e2bf7639390 35 fields · synced Jun 1, 2026