Duns Number:139424188
Device Description: Prolystica 2X Concentrate Neutral 1-Gallon is designed for use in both manual and automate Prolystica 2X Concentrate Neutral 1-Gallon is designed for use in both manual and automated cleaning of appropriate medical devices including surgical instruments.
Catalog Number
1C3208
Brand Name
Prolystica
Version/Model Number
1C3208
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
b0753cee-2c18-4e13-a2aa-57814b1c08f6
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
50724995090963
Quantity per Package
4
Contains DI Package
00724995090968
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 |