Duns Number:480420090
Device Description: Irriflex is a flexible cannula with radial opening for liquid ejection along the canal wal Irriflex is a flexible cannula with radial opening for liquid ejection along the canal walls.
Catalog Number
21403
Brand Name
Irriflex
Version/Model Number
21403
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 13, 2022
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
Yes
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
EIC
Product Code Name
Syringe, Periodontic, Endodontic, Irrigating
Public Device Record Key
64a3b0d3-9c6a-4a54-9ee8-010a2a344f7e
Public Version Date
June 14, 2022
Public Version Number
2
DI Record Publish Date
September 10, 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 | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |