Duns Number:008496861
Device Description: Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of Wavicide-01 is a glutaraldehyde-based product intended for the high-level disinfection of flexible fiber-optic endoscopes.
Catalog Number
0104-1gl IRI
Brand Name
Wavicide-01
Version/Model Number
0104-1gl IRI
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
K914749,K914749
Product Code
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
65a97b29-f1cc-4af5-8f8e-0766bfa5225e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
M44501041GLIRI1
Quantity per Package
12
Contains DI Package
M44501041GLIRI0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |