Identity
- Trade Name
- SkyPlate large FDA UDI
- Generic Name
- Indirect flat panel x-ray detector FDA UDI
- Device Name
- Solid State X-Ray Imager (Flat Panel/Digital Imager) FDA UDI
- Model / Reference
- 9897-010-00834 FDA UDI
- Description
- Solid State X-Ray Imager (Flat Panel/Digital Imager) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838065222 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Indirect flat panel x-ray detector 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
Yes
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
No
FDA UDI
SkyPlate large by Philips Medical Systems GmbH, Dmc — 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
- Philips Medical Systems GmbH, Dmc
Sources (1)
- FDA UDI 49bfa457-c676-4181-83c4-3c7fc22d58d6 34 fields · synced May 30, 2026