Duns Number:139424188
Device Description: Prolystica Ultra Concentrate Alkaline Detergent 5 Liter is designed for automated cleaning Prolystica Ultra Concentrate Alkaline Detergent 5 Liter is designed for automated cleaning including hospital washer disinfectors and automated mechanical washers.
Catalog Number
1C12T4WR
Brand Name
Prolystica
Version/Model Number
1C12T4WR
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
f53e7a23-1276-44fb-9faa-dde8dc16aa0f
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
50724995089615
Quantity per Package
2
Contains DI Package
00724995089610
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 |