Duns Number:947451626
Device Description: Cidex Activated Dialdehyde 4.7 Liter
Catalog Number
2266
Brand Name
Cidex
Version/Model Number
2266
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
K060618,K060618
Product Code
MED
Product Code Name
Sterilant, medical devices
Public Device Record Key
69e1d42f-4e83-4237-9a85-f51e8eec5703
Public Version Date
March 19, 2021
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
20705037044587
Quantity per Package
4
Contains DI Package
10705037044580
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 | 20 |
2 | A medical device with a moderate to high risk that requires special controls. | 159 |