Duns Number:608235214
Device Description: IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 58IN. MONITOR,TELESCOPIC,ILEX W/MSV2,120V,#A280-098 IDI,MOBILE VIDEO DISPLAY SYSTEM,SINGLE 58IN. MONITOR,TELESCOPIC,ILEX W/MSV2,120V,#A280-0981
Catalog Number
A280-0981
Brand Name
IMAGE DIAGNOSTICS, INC
Version/Model Number
ilex58 W/MSV2, 120V
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
LMD
Product Code Name
System, Digital Image Communications, Radiological
Public Device Record Key
ee3b8fd8-dd15-4365-8ed4-16711b1f47a7
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
April 01, 2020
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 |