Duns Number:144884467
Catalog Number
-
Brand Name
AngioSystems SorbX
Version/Model Number
SX8330NS
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K843260,K843260
Product Code
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
4ddff5cd-72b2-481a-9ed9-ebfd0af68644
Public Version Date
November 19, 2018
Public Version Number
1
DI Record Publish Date
October 19, 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 | 170 |
2 | A medical device with a moderate to high risk that requires special controls. | 88 |
U | Unclassified | 1 |