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
10-1400
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,K930284
Product Code
MED
Product Code Name
Sterilant, medical devices
Public Device Record Key
23ecbcb1-d590-4b2e-87e6-bc375ad9792c
Public Version Date
November 11, 2021
Public Version Number
4
DI Record Publish Date
August 31, 2016
Package DI Number
10615375005450
Quantity per Package
4
Contains DI Package
00615375005453
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 |