Duns Number:093357739
Device Description: MI-550 Examination Light, Wall Mount
Catalog Number
-
Brand Name
MI Product Line
Version/Model Number
061322
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
KZF
Product Code Name
Device, Medical Examination, Ac Powered
Public Device Record Key
6108c8ac-d71c-46f8-8a0e-c6abb4e9312c
Public Version Date
September 19, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
01816835020231
Quantity per Package
1
Contains DI Package
00816835020232
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 112 |
2 | A medical device with a moderate to high risk that requires special controls. | 58 |