Duns Number:139424188
Device Description: Prolystica Ultra Concentrate HP Neutral 5 Liter is designed for use in hospital washer-dis Prolystica Ultra Concentrate HP Neutral 5 Liter is designed for use in hospital washer-disinfector units and automated mechanical washers.
Catalog Number
1C15T4
Brand Name
Prolystica
Version/Model Number
1C15T4
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
35c4a83c-7d4b-4993-b38d-8da3d0d1056b
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
50724995000689
Quantity per Package
2
Contains DI Package
00724995000684
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 |