Identity
- Trade Name
- Patient Support Board FDA UDI
- Generic Name
- Basic diagnostic x-ray system table, powered FDA UDI
- Device Name
- ORT 400 table, Patient Support Board with Label 119749-000 FDA UDI
- Model / Reference
- 119749-000 FDA UDI
- Description
- ORT 400 table, Patient Support Board with Label 119749-000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857534006714 FDA UDI
- FDA Product Code
- KXJ FDA UDIGDC FDA UDI
- GMDN Term
- Basic diagnostic x-ray system table, powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1980 FDA UDI878.4960 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
No
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 Safe FDA UDI
Category: Basic diagnostic x-ray system table, poweredMRI system table, powered
Patient Support Board by IMRIS Imaging, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- IMRIS Imaging, Inc.
Sources (1)
- FDA UDI a02f6d74-e0cb-4f21-ab34-5923bc7ec8fc 33 fields · synced Jun 8, 2026