Duns Number:202659140
Device Description: The SYSTEM 1E Liquid Chemical Sterilant Processing System is for safe and effective reproc The SYSTEM 1E Liquid Chemical Sterilant Processing System is for safe and effective reprocessing of heat-sensitive critical and semi-critical medical devices. This unit is distributed through the STERIS Placement Program.
Catalog Number
7500PLACE
Brand Name
SYSTEM 1E Liquid Chemical Sterilant Processing System - Placement Program
Version/Model Number
1E
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 14, 2021
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
MED
Product Code Name
Sterilant, medical devices
Public Device Record Key
20994f2f-2a02-4627-b2d5-9f51cd96d3e1
Public Version Date
June 14, 2021
Public Version Number
9
DI Record Publish Date
September 23, 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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |