FDA UDI
In Commercial Distribution
🇺🇸 United States
ORT400 Table
DI: 00857534006691
·
Model: 119900-000
·
IMRIS Imaging, Inc.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ORT400 Table
- Primary DI
- 00857534006691
- Version / Model
- 119900-000
- Company Name
- IMRIS Imaging, Inc.
- Labeler DUNS
- 079990922
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-04
- Public Version
- 2
- Public Version Date
- 2025-04-08
- Public Version Status
- Update
- Public Device Record Key
- e6c029a3-7d3b-49de-b651-576e23a59ff0
Device Description
ORT400 Table
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDC | Table, Operating-Room, Electrical | General, Plastic Surgery | 878.4960 | 1 |
| KXJ | Table, Radiologic | Radiology | 892.1980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40655 | Basic diagnostic x-ray system table, powered | A powered/programmable table that is a component of a basic diagnostic x-ray system designed to position and support a patient during a variety of routine/planar or speciality diagnostic procedures requiring the use of a diagnostic x-ray system; it is not a planar tomography nor computed tomography (CT) table. It can be a stationary or mobile unit and is made of radiolucent materials with low x-ray attenuation coefficients. It is not intended for use during interventional radiology/surgery. | No | Active |
| 40676 | MRI system table, powered | A powered/programmable table designed with electronic and/or software controls to position and support a patient during magnetic resonance imaging (MRI) examinations. It is dedicated for use as part of an MRI system, as an integral component of the MRI system gantry, and made with ferromagnetically inactive materials to render it compatible with MRI environments. It may have a detachable table top, equipment supports, physiological monitors, mattresses, alarms and a patient positioning system (PPS). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857534006691 | GS1 |