Duns Number:021717889
Device Description: Cleaning Sponge plus Pure™ Enzymatic
Catalog Number
SES-240
Brand Name
Koala™
Version/Model Number
SES-240
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)
Yes
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
9804c5e4-74ea-4edb-998a-35c48a6beed8
Public Version Date
July 08, 2021
Public Version Number
4
DI Record Publish Date
March 29, 2019
Package DI Number
00816849015569
Quantity per Package
50
Contains DI Package
00840253120298
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |