Duns Number:079105071
Device Description: Stiffened Micro Introducer Kit
Catalog Number
-
Brand Name
AngioDynamics
Version/Model Number
06597070
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051655
Product Code
DQR
Product Code Name
CANNULA, CATHETER
Public Device Record Key
4821379a-8dee-4244-8151-c3d3733f1768
Public Version Date
February 08, 2021
Public Version Number
5
DI Record Publish Date
September 19, 2016
Package DI Number
H787065970705
Quantity per Package
10
Contains DI Package
H787065970700
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 203 |