Duns Number:790776850
Device Description: MT VALUE SCALER N128 DE (3/8)
Catalog Number
MN128DEX
Brand Name
American Eagle Instruments
Version/Model Number
MN128DEX
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
EMN
Product Code Name
SCALER, PERIODONTIC
Public Device Record Key
127e30f3-8067-485b-8776-a3cee98257f7
Public Version Date
October 05, 2022
Public Version Number
3
DI Record Publish Date
July 24, 2022
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 | 1253 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |