Duns Number:005036025
Device Description: The Midmark Elevance and Procenter LR Mounted (with Lowered Cut-Out for Monitor Mount) Den The Midmark Elevance and Procenter LR Mounted (with Lowered Cut-Out for Monitor Mount) Dental LED Light is intended to be used as a component in a dental environment to provide lighting during dental procedures.
Catalog Number
153901-008
Brand Name
Midmark
Version/Model Number
153901-008
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
8a0a3ce5-4b11-49ea-9e34-036fd7c1b100
Public Version Date
July 02, 2018
Public Version Number
1
DI Record Publish Date
May 31, 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 |