Duns Number:244261462
Device Description: M20A-IS/E6, Air Motor, E6 Backend, Internal Spray, Fiber Optic, 20k
Catalog Number
-
Brand Name
Maxso M20A-IS/E6
Version/Model Number
MT2007
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
EGS
Product Code Name
Handpiece, Contra- And Right-Angle Attachment, Dental
Public Device Record Key
4d20d77d-be43-46c6-ab95-05b6939ddd8a
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
April 12, 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 | 150 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |
| U | Unclassified | 6 |