Duns Number:103169095
Device Description: Krinkle pad and concentrated Simple2 detergent to mix with 4 gallons of water
Catalog Number
-
Brand Name
Krinkle pad and concentrated Simple2 detergent to mix with 4 gallons of water
Version/Model Number
EDK04
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MNL
Product Code Name
Accessories, Cleaning Brushes, For Endoscope
Public Device Record Key
10c598e3-48cc-4244-881f-df25c3981a27
Public Version Date
July 23, 2021
Public Version Number
1
DI Record Publish Date
July 15, 2021
Package DI Number
10843356102656
Quantity per Package
100
Contains DI Package
00843356102659
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 146 |