Duns Number:079723355
Device Description: MEDILECTRIC ELECTRIC HANDPIECE SYSTEM
Catalog Number
EJ0008-MEDI
Brand Name
MEDIDENTA
Version/Model Number
EJ0008-MEDI
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
-
Product Code
EBW
Product Code Name
Controller, Foot, Handpiece And Cord
Public Device Record Key
17e249b0-e5c6-41ec-bf36-9c096a394114
Public Version Date
May 30, 2022
Public Version Number
1
DI Record Publish Date
May 20, 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 | 68 |