Duns Number:695798956
Device Description: sterilant for Low temperature plasma sterilizer STERLINK™ FPS-15s Plus.The STERLOAD is gro sterilant for Low temperature plasma sterilizer STERLINK™ FPS-15s Plus.The STERLOAD is group of sterilant cassette products which are designed to be used only by STERLINK™ sterilizer products, low temperature plasma sterilization system. The STERLOAD is supposed to be inserted in the STERLINK™ chamber to proceed sterilization process.
Catalog Number
-
Brand Name
STERLINK™
Version/Model Number
STERLOAD
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
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
K212200
Product Code
MLR
Product Code Name
Sterilizer, Chemical
Public Device Record Key
b17b6c2b-43a4-4a31-a274-a1cc65d94a51
Public Version Date
December 06, 2021
Public Version Number
1
DI Record Publish Date
November 26, 2021
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |