Duns Number:622766397
Device Description: Non-Elevating Radiographic Patient Table HXVF
Catalog Number
04000
Brand Name
aries
Version/Model Number
04000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 16, 2017
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
IXQ
Product Code Name
Table, Radiographic, Stationary Top
Public Device Record Key
02f1ac15-fdbd-494a-bc9b-457dda22562a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 12, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |