Duns Number:622185718
Device Description: CanalPro CL2 Intro Kit
Catalog Number
-
Brand Name
CanalPro
Version/Model Number
60018361
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K123582
Product Code
EKX
Product Code Name
Handpiece, Direct Drive, Ac-Powered
Public Device Record Key
c38a8568-5ffe-4693-a1f4-47268d4c4230
Public Version Date
November 05, 2018
Public Version Number
1
DI Record Publish Date
October 03, 2018
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 | 553 |
2 | A medical device with a moderate to high risk that requires special controls. | 248 |
U | Unclassified | 10 |