Duns Number:068199363
Catalog Number
-
Brand Name
Rapicide High Level Disinfectant and Sterilant
Version/Model Number
ML02-0059
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
K993042,K993042
Product Code
MED
Product Code Name
Sterilant, Medical Devices
Public Device Record Key
99e84bf8-3796-42eb-baea-2385a378713c
Public Version Date
April 27, 2022
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
30677964034856
Quantity per Package
4
Contains DI Package
00677964034855
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 |