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.
Catalog Number
6500
Brand Name
SYSTEM 1E Liquid Chemical Sterilant Processing System
Version/Model Number
1E
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090036,K101409,K102462,K113520,K131078,K161683,K170956,K180342,K190104,K192929,K210737,K211607,K222615
Product Code
MED
Product Code Name
Sterilant, medical devices
Public Device Record Key
230c69a3-e931-41a2-bd78-f841d26fedee
Public Version Date
October 20, 2022
Public Version Number
8
DI Record Publish Date
September 13, 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 |