Duns Number:343831731
Device Description: EndoPilot Motor with ISO-E standard; LED-indicator and Apex-contact
Catalog Number
109 0112
Brand Name
EndoPilot Motor
Version/Model Number
EDP2
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
K202906
Product Code
EKX
Product Code Name
Handpiece, Direct Drive, Ac-Powered
Public Device Record Key
2e965434-ab51-49c3-9b2b-b55eb2f22ef8
Public Version Date
June 10, 2021
Public Version Number
1
DI Record Publish Date
June 02, 2021
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 | 11 |
2 | A medical device with a moderate to high risk that requires special controls. | 1 |
U | Unclassified | 6 |