Duns Number:437222573
Device Description: The CLEANASCOPE ADVANTAGE Sterile Liner System consists of sterile red and green covers an The CLEANASCOPE ADVANTAGE Sterile Liner System consists of sterile red and green covers and a sterile clear base liner to be used as part of the CLEANASCOPE ADVANTAGE system that provides identification of Clean and Contaminated equipment.
Catalog Number
103585
Brand Name
CLEANASCOPE Advantage
Version/Model Number
Sterile Tray Liner System
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)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FFY
Product Code Name
Adaptor, bulbs, miscellaneous, for endoscope
Public Device Record Key
982a61de-3ce8-4845-8889-22fc663dd8e8
Public Version Date
October 10, 2022
Public Version Number
1
DI Record Publish Date
September 30, 2022
Package DI Number
38011517135850
Quantity per Package
200
Contains DI Package
18011517135856
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |