Duns Number:005036025
Device Description: Midmark LED retrofit kit to bring the performance and efficiency of the Midmark LED operat Midmark LED retrofit kit to bring the performance and efficiency of the Midmark LED operatory light to the Track, Cabinet and Wall Mounted Operatory Lights.
Catalog Number
002-1530-00
Brand Name
Midmark
Version/Model Number
002-1530-00
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
EAZ
Product Code Name
LIGHT, OPERATING, DENTAL
Public Device Record Key
8f9e5076-00f0-4493-99cf-da003fa68d32
Public Version Date
August 27, 2018
Public Version Number
1
DI Record Publish Date
July 27, 2018
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 | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |