Duns Number:005036025
Device Description: Midmark Asepsis 21 Hygienist's Cart Delivery Systems are intended to provide dental profes Midmark Asepsis 21 Hygienist's Cart Delivery Systems are intended to provide dental professionals with air, water and suction to operate dental handpieces, syringes, and Midmark authorized accessories during dental examinations and procedures.
Catalog Number
153740-004
Brand Name
Midmark
Version/Model Number
153740-004
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
K003090
Product Code
EIA
Product Code Name
Unit, operative dental
Public Device Record Key
70e88e40-0a8b-45eb-9bf9-bb731a383ce8
Public Version Date
August 14, 2020
Public Version Number
1
DI Record Publish Date
August 06, 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 | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |