Duns Number:139424188
Device Description: 3E-Zyme Triple Enzyme Cleaner, 1 Gallon offers rapid soil removal with low temperature act 3E-Zyme Triple Enzyme Cleaner, 1 Gallon offers rapid soil removal with low temperature activation.
Catalog Number
MEDIS12041
Brand Name
3E-Zyme
Version/Model Number
MEDIS12041
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLG
Product Code Name
Cleaner, ultrasonic, medical instrument
Public Device Record Key
3e6bb178-befa-41ab-858b-a45763773717
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
50724995179682
Quantity per Package
4
Contains DI Package
00724995179687
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |