Duns Number:608235214
Device Description: IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,30" - 35" TABLETOP WIDTH IDI,RADIATION SHIELD SYSTEM,PROTEGO,MOBILE,METRIC ACCESSORY RAILS,30" - 35" TABLETOP WIDTH,#A800-0004
Catalog Number
A800-0004
Brand Name
IMAGE DIAGNOSTICS, INC
Version/Model Number
Protego MRS System for Large Table Tops w/Metric Accessory Rails
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
IWX
Product Code Name
Barrier, Control Panel, X-Ray, Movable
Public Device Record Key
96efffc3-d1c4-4d7f-8f49-35e08905dcb0
Public Version Date
March 02, 2021
Public Version Number
1
DI Record Publish Date
February 22, 2021
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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 49 |