Identity
- Trade Name
- ORT300 Table FDA UDI
- Generic Name
- Basic diagnostic x-ray system table, powered FDA UDI
- Device Name
- ORT300 Modular Table Main Unit Assy, 114093-000 FDA UDI
- Model / Reference
- ORT300 FDA UDI
- Description
- ORT300 Modular Table Main Unit Assy, 114093-000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857534006356 FDA UDI
- FDA Product Code
- FQO FDA UDIKXJ FDA UDI
- GMDN Term
- Basic diagnostic x-ray system table, powered FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4960 FDA UDI892.1980 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Basic diagnostic x-ray system table, powered
ORT300 Table by IMRIS Imaging, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- IMRIS Imaging, Inc.
Sources (1)
- FDA UDI 07b87c22-ea0d-4b7f-973c-2fc0d2a49213 33 fields · synced May 30, 2026