Duns Number:556957871
Device Description: Cannula 14mm Stainless Steel, Non-Sterile
Catalog Number
3910142.014
Brand Name
Cannula 14mm SS, Non-Sterile
Version/Model Number
14mm SS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K971571
Product Code
KDN
Product Code Name
System, Perfusion, Kidney
Public Device Record Key
0b77c490-ed34-4802-a26a-b920e5c5f963
Public Version Date
March 21, 2019
Public Version Number
3
DI Record Publish Date
May 02, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 53 |