Duns Number:139424188
Device Description: Valsure Neutral Detergent, 1-Gallon is formulated to be used in manual and automated clean Valsure Neutral Detergent, 1-Gallon is formulated to be used in manual and automated cleaning, including ultrasonic cleaners, washer-disinfectors and other similar equipment.
Catalog Number
1C5408
Brand Name
Valsure
Version/Model Number
1C5408
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
52fabeca-19b4-4618-a9e3-7ab7c4acbf6b
Public Version Date
April 08, 2021
Public Version Number
1
DI Record Publish Date
March 31, 2021
Package DI Number
50724995088779
Quantity per Package
4
Contains DI Package
00724995088774
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 |