Duns Number:569317142
Device Description: The HexaLux Exam Mobile Light without Batteries is a powerful, next-generation LED exam l The HexaLux Exam Mobile Light without Batteries is a powerful, next-generation LED exam light designed to be used in a multitude of rooms including the exam room, birthing suite, or intensive care unit.
Catalog Number
EXLMNBHUS
Brand Name
HexaLux
Version/Model Number
HexaLux Light Mobile
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)
Yes
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
73c317f6-bf7a-4fa0-93a0-150df7371c36
Public Version Date
January 26, 2021
Public Version Number
3
DI Record Publish Date
June 30, 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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |