Duns Number:832696038
Device Description: GENESIS NON-CELLULOSE FILTER 9.5” X 9.5” (24 X 24 CM)
Catalog Number
DST-3
Brand Name
V. Mueller
Version/Model Number
DST-3
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
-
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
97852771-a5a4-4d16-a7e8-4f6c84799c6f
Public Version Date
January 10, 2020
Public Version Number
4
DI Record Publish Date
September 21, 2016
Package DI Number
20885403187480
Quantity per Package
4
Contains DI Package
70885403187485
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 | 8016 |
2 | A medical device with a moderate to high risk that requires special controls. | 6223 |