FDA UDI
In Commercial Distribution
🇺🇸 United States
Del Medical/Universal
DI: 00858340006028
·
Model: EV800
·
Del Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Del Medical/Universal
- Primary DI
- 00858340006028
- Version / Model
- EV800
- Company Name
- Del Medical, Inc.
- Labeler DUNS
- 078671236
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-17
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- b37bd87d-0a82-44f7-9632-03f2733f9479
Device Description
The EV800 elevating table is designed for general purpose radiography and features a four-way floating table top with longitudinal and transverse travel. It uses electromechanical locks to maintain the desired position. It has a motor-driven telescopic base that can raise and lower the table top. It has a patient weight limit of 800 lbs.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IZZ | Table, Radiographic, Non-Tilting, Powered | 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858340006028 | GS1 |
Customer Contacts
- Phone
- 847-288-7000
- [email protected]