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Patient-Specific TMJ Fossa-Eminence Trial Sizer (LEFT SIDE)
FDA UDIClass III (US FDA UDI)
Identity
- Trade Name
- Patient-Specific TMJ Fossa-Eminence Trial Sizer (LEFT SIDE) FDA UDI
- Generic Name
- Mandibular fossa prosthesis FDA UDI
- Device Name
- Patient-Specific TMJ Fossa-Eminence Trial Sizer (LEFT SIDE) FDA UDI
- Model / Reference
- 500107 FDA UDI
- Description
- Patient-Specific TMJ Fossa-Eminence Trial Sizer (LEFT SIDE) FDA UDI
Identifiers
- Primary DI / UDI-DI
- M9575001070 FDA UDI
- FDA Product Code
- LZD FDA UDIMPI FDA UDI
- GMDN Term
- Mandibular fossa prosthesis FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 872.3940 FDA UDI872.3950 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Patient-Specific TMJ Fossa-Eminence Trial Sizer (LEFT SIDE) by Nexus Cmf, L.L.C. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 III | Pending data |
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Manufacturer
- Manufacturer
- Nexus Cmf, L.L.C.
Sources (1)
- FDA UDI 2d1d4372-e857-4ba4-ae9f-6da88f75b9f5 34 fields · synced May 30, 2026