Duns Number:139424188
Device Description: Prolystica 2X Concentrate Enzymatic Presoak and Cleaner 5 Liter is a low foaming cleaner d Prolystica 2X Concentrate Enzymatic Presoak and Cleaner 5 Liter is a low foaming cleaner designed for both manual and automated cleaning.
Catalog Number
1C33T4PE
Brand Name
Prolystica
Version/Model Number
1C33T4PE
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
fbb4de97-4334-4da1-b0e4-dab05842d76e
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
50724995090833
Quantity per Package
2
Contains DI Package
00724995090838
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 |