Duns Number:145963778
Device Description: Sterilizing & Disinfecting Solution 14Day Glutaraldehyde Dialdehyde Solution 2.6% Glutar Sterilizing & Disinfecting Solution 14Day Glutaraldehyde Dialdehyde Solution 2.6% Glutaraldehyde
Catalog Number
-
Brand Name
MetriCide
Version/Model Number
10-1405
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
K930284
Product Code
MED
Product Code Name
Sterilant, medical devices
Public Device Record Key
147bc23a-c10c-420b-ac60-1d206b6a6d50
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2016
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |