Duns Number:505942961
Device Description: The Niagara Sonic Irrigatior PCF Washer Disinfector has a built in ultrasonic chamber for The Niagara Sonic Irrigatior PCF Washer Disinfector has a built in ultrasonic chamber for Sonic Irrigation cleaning of 48 lumen OR 20 da Vinci instruments.
Catalog Number
MED1406
Brand Name
NA
Version/Model Number
Niagara Sonic Irrigator PCF
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 11, 2020
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
MEC
Product Code Name
Disinfector, medical devices
Public Device Record Key
28e1c92e-c9d8-45b2-97f5-a77c01c19a7c
Public Version Date
September 11, 2020
Public Version Number
5
DI Record Publish Date
September 16, 2016
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |