Duns Number:144884467
Catalog Number
-
Brand Name
AngioSystems Tray
Version/Model Number
KM5078
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 30, 2050
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
K905462,K905462
Product Code
LRP
Product Code Name
Tray, Surgical
Public Device Record Key
67f31d7b-8377-4953-be68-4fc13accc268
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
March 31, 2022
Package DI Number
00816611027110
Quantity per Package
20
Contains DI Package
00816611029992
Package Discontinue Date
March 30, 2050
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 | 170 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 88 |
| U | Unclassified | 1 |