Duns Number:961394798
Device Description: The Steam Filter Cartridge Kit, is used with the Sterilization Container System. It contai The Steam Filter Cartridge Kit, is used with the Sterilization Container System. It contains 1000 filter cartridges for steam sterilization, 1336 tamper evident devices, and 500 indicator cards.
Catalog Number
SC1361
Brand Name
NA
Version/Model Number
SC1361
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 14, 2022
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
Yes
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
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
a012eca8-439d-44b5-a743-861b0d99c21e
Public Version Date
January 14, 2022
Public Version Number
10
DI Record Publish Date
September 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |