Duns Number:262277122
Catalog Number
-
Brand Name
STA® - Cleaner Solution
Version/Model Number
00973
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PPM
Product Code Name
General purpose reagent
Public Device Record Key
2a3559b2-6225-4a8b-be2d-cd56be9e9ad4
Public Version Date
July 27, 2022
Public Version Number
3
DI Record Publish Date
September 29, 2020
Package DI Number
13607450009733
Quantity per Package
6
Contains DI Package
03607450009736
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 4 |
2 | A medical device with a moderate to high risk that requires special controls. | 57 |