Duns Number:093357739
Device Description: MI-750 Minor Surgical Light, Floor Stand with Battery Back-up
Catalog Number
-
Brand Name
Vistor PR LED
Version/Model Number
NV061423B
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
K140812,K140812
Product Code
FSY
Product Code Name
Light, Surgical, Ceiling Mounted
Public Device Record Key
923f693b-d96a-4529-b7c5-230495dddfe5
Public Version Date
September 19, 2022
Public Version Number
7
DI Record Publish Date
September 23, 2016
Package DI Number
01816835020552
Quantity per Package
1
Contains DI Package
00816835020553
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 |