Duns Number:080214481
Device Description: Micro-Cide 28 HLD - 3 % Glutaraldehyde Reusable Sterilizing and High Level Disinfecting So Micro-Cide 28 HLD - 3 % Glutaraldehyde Reusable Sterilizing and High Level Disinfecting Solution
Catalog Number
-
Brand Name
Micro-Scientific
Version/Model Number
MICROCIDE1
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
Yes
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
5a127958-0a27-4122-a67f-72c77067f3e7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 07, 2016
Package DI Number
10739470500013
Quantity per Package
4
Contains DI Package
00739470500016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |