Duns Number:009260217
Device Description: Ultra concentrated enzymatic evacuation cleaner and instrument pre-soak; orange scented, n Ultra concentrated enzymatic evacuation cleaner and instrument pre-soak; orange scented, non foaming, non toxic, noncorrosive, 900 g pouch
Catalog Number
15270
Brand Name
Citrizyme Ultra Concentrated Enzymatic Powder 900g
Version/Model Number
15270
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MDZ
Product Code Name
Cleaners, Medical Devices
Public Device Record Key
b60adfa4-8d95-4139-ac1b-f598427ed13d
Public Version Date
August 09, 2019
Public Version Number
2
DI Record Publish Date
January 24, 2019
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 | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| U | Unclassified | 57 |