Duns Number:078671236
Device Description: The EV650 elevating table is designed for general purpose radiography and features a four- The EV650 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 650 lbs.
Catalog Number
-
Brand Name
Del Medical/Universal
Version/Model Number
EV650
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IZZ
Product Code Name
Table, Radiographic, Non-Tilting, Powered
Public Device Record Key
da3b7cbb-4ee9-4c1d-82c7-092a7ca22482
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |