Duns Number:505942961
Device Description: The InnoWave Ortho Basket Drop plus Lock for the InnoWave PCF Sonic Irrigator.
Catalog Number
IW1006
Brand Name
N/A
Version/Model Number
IW1006
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 18, 2021
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
9bb3a4ee-1c59-4f35-bfdd-0c342b737086
Public Version Date
March 18, 2021
Public Version Number
6
DI Record Publish Date
February 21, 2017
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 |