Duns Number:005036025
Device Description: Midmark 4 Position Elevance Console Mounted Traditional Instrument Delivery Systems are in Midmark 4 Position Elevance Console Mounted Traditional Instrument Delivery Systems are intended to provide dental professionals with air, water, and suction along with low-voltage electricity to operate dental handpieces, syringes, and accessories during dental examinations and treatments.
Catalog Number
153800-013
Brand Name
Midmark
Version/Model Number
153800-013
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120239
Product Code
EIA
Product Code Name
Unit, operative dental
Public Device Record Key
4acdc20e-43f5-46be-bff8-3948d25b980d
Public Version Date
May 17, 2021
Public Version Number
1
DI Record Publish Date
May 07, 2021
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 |