Duns Number:145963778
Device Description: orthoPhthalaldehyde Solution high level disinfectant for semicritical medical devices
Catalog Number
-
Brand Name
MetriCide OPA Plus
Version/Model Number
10-6000
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
87067a07-9795-4fcc-9549-76a6b1832af9
Public Version Date
November 11, 2021
Public Version Number
6
DI Record Publish Date
August 31, 2016
Package DI Number
10615375006433
Quantity per Package
4
Contains DI Package
00615375006436
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 |