Duns Number:009260217
Device Description: Reusable 3.4% Glutaraldehyde Sterilizing & Disinfecting Solution; 1 gallonSterilization, h Reusable 3.4% Glutaraldehyde Sterilizing & Disinfecting Solution; 1 gallonSterilization, high level disinfection and cleaning/decontamination solution.
Catalog Number
15200
Brand Name
Banicide Plus Sterilizing and Disinfecting Solution
Version/Model Number
15200
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
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
6cc78f29-9523-41ab-87ec-f12eb3c83bd9
Public Version Date
March 01, 2019
Public Version Number
1
DI Record Publish Date
January 29, 2019
Package DI Number
20310866000002
Quantity per Package
144
Contains DI Package
00310866000008
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pallet
| 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 |