Duns Number:005036025
Device Description: Midmark PowerMax Surgical Vacuums are intended to provide suction during procedures conduc Midmark PowerMax Surgical Vacuums are intended to provide suction during procedures conducted by qualified dental professionals. Model: PM-1, Number of users: 1, CFM Maximum: 8, Total HP: 1 @ 3/4 HP.
Catalog Number
PM-1
Brand Name
Midmark
Version/Model Number
PM-1
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
NRD
Product Code Name
Unit, operative dental, accessories
Public Device Record Key
d73f6ed8-417c-4b7e-86da-c29bd9740007
Public Version Date
April 07, 2022
Public Version Number
4
DI Record Publish Date
February 08, 2019
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 |