Duns Number:145963778
Device Description: Sterilizing & Disinfecting Solution 28Day Glutaraldehyde Dialdehyde Solution 2.5% Gluta Sterilizing & Disinfecting Solution 28Day Glutaraldehyde Dialdehyde Solution 2.5% Glutaraldehyde
Catalog Number
-
Brand Name
ProCide-D
Version/Model Number
10-2860
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
-
Product Code
MED
Product Code Name
Sterilant, medical devices
Public Device Record Key
f4cecfb2-c945-4ea6-8555-77d1d02a31de
Public Version Date
September 10, 2021
Public Version Number
3
DI Record Publish Date
August 31, 2016
Package DI Number
10615375005481
Quantity per Package
4
Contains DI Package
00615375005484
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |