Duns Number:008496861
Device Description: The Wavicide MEC Indicator is a semi-quantitative indicator designed to monitor the glutar The Wavicide MEC Indicator is a semi-quantitative indicator designed to monitor the glutaraldehyde concentration of Wavicide-01.
Catalog Number
0306-Strips
Brand Name
Wavicide MEC Indicator
Version/Model Number
0306-Strips
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K924681,K924681
Product Code
JOJ
Product Code Name
Indicator, Physical/Chemical Sterilization Process
Public Device Record Key
242a01d5-8d06-41aa-8200-7e6378069202
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
M44503061
Quantity per Package
6
Contains DI Package
M44503060
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 |