Duns Number:202659140
Device Description: The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterila The SYSTEM 1 endo Liquid Chemical Sterilant Processing System is a liquid chemical sterilant processor designed to safely and effectively reprocess heat-sensitive, semi-critical medical devices.
Catalog Number
P6800
Brand Name
SYSTEM 1 endo Liquid Chemical Sterilant Processing System
Version/Model Number
endo
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 30, 2020
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
K173256,K182827,K190104,K192929
Product Code
MED
Product Code Name
Sterilant, medical devices
Public Device Record Key
9096dae6-a089-4727-9a02-81e044f9cc73
Public Version Date
September 30, 2020
Public Version Number
5
DI Record Publish Date
July 03, 2018
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 |