Duns Number:068199363
Device Description: Rapicide PA High-Level Disinfectant
Catalog Number
ML020117
Brand Name
Rapicide PA High-Level Disinfectant
Version/Model Number
ML02-0117
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
K082988,K082988,K082988
Product Code
FEB
Product Code Name
Accessories, Cleaning, For Endoscope
Public Device Record Key
1e182fc4-3d56-4b0f-8902-38139f14e0a7
Public Version Date
June 21, 2022
Public Version Number
9
DI Record Publish Date
September 16, 2016
Package DI Number
30677964063610
Quantity per Package
2
Contains DI Package
00677964063619
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 |