Identity
- Trade Name
- GXPS-500 FDA UDI
- Generic Name
- Dental computed radiography digital imaging scanner FDA UDI
- Model / Reference
- GXPS-500 FDA UDI
Identifiers
- Catalog Number
- 900469 FDA UDI
- Primary DI / UDI-DI
- 06430035872497 FDA UDI
- 510(k) Number
- K041050 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Dental computed radiography digital imaging scanner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Gxps-500 by PaloDEx Group Oy — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- PaloDEx Group Oy
Sources (1)
- FDA UDI c45870c3-f49e-48fa-9eb8-45d53b77d4ae 36 fields · synced Jun 1, 2026