Duns Number:505942961
Device Description: The Si Basket Tubing 10 is used with the IW PCF and or SI PCF S Sonic Irrigators.
Catalog Number
IW1064
Brand Name
Niagara
Version/Model Number
MP22062
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MEC
Product Code Name
Disinfector, medical devices
Public Device Record Key
d0e50e05-acd1-495b-b120-1510833912f3
Public Version Date
March 26, 2021
Public Version Number
1
DI Record Publish Date
March 18, 2021
Package DI Number
15060247265275
Quantity per Package
10
Contains DI Package
05060247265278
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |