Duns Number:961394798
Device Description: The ETO Filter Cartridge Kit, is used with the Sterilization Container System. It contains The ETO Filter Cartridge Kit, is used with the Sterilization Container System. It contains 200 filter cartridges for ETO sterilization, 270 tamper evident devices, and 125 indicator cards.
Catalog Number
SC1363
Brand Name
NA
Version/Model Number
SC1363
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 28, 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
K850289
Product Code
FRG
Product Code Name
Wrap, sterilization
Public Device Record Key
b9eda3c4-e14d-4211-a28c-fa6b3398d3ae
Public Version Date
October 31, 2022
Public Version Number
9
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 |