Duns Number:144884467
Catalog Number
-
Brand Name
AngioSystems Drape
Version/Model Number
3014
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
210abee7-4a2f-429e-b937-8bd702082eb6
Public Version Date
December 22, 2021
Public Version Number
6
DI Record Publish Date
June 15, 2016
Package DI Number
00816611020043
Quantity per Package
25
Contains DI Package
00816611020036
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |