Duns Number:068199363
Catalog Number
-
Brand Name
Rapicide OPA/28 High-Level Disinfectant
Version/Model Number
ML02-0127
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120306,K120306
Product Code
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
553ad304-5c6b-4d38-9942-0f8be7779736
Public Version Date
April 27, 2022
Public Version Number
8
DI Record Publish Date
September 16, 2016
Package DI Number
30677964054267
Quantity per Package
4
Contains DI Package
00677964054266
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2999 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 362 |