Duns Number:788472314
Device Description: Cardio Kit Containing (1) 9Fr Single Hemostasis Valve, (1) 20GAx5" Insertion Tool and (1) Cardio Kit Containing (1) 9Fr Single Hemostasis Valve, (1) 20GAx5" Insertion Tool and (1) 0.009 - 0.018" Guidewire Torque Device
Catalog Number
NK-01
Brand Name
Necessities Kit
Version/Model Number
NK-01
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
-
Product Code
OEQ
Product Code Name
Angiography/angioplasty kit
Public Device Record Key
691ec14d-5703-44ee-9a30-f7993b530003
Public Version Date
December 11, 2018
Public Version Number
1
DI Record Publish Date
November 10, 2018
Package DI Number
20813079022606
Quantity per Package
12
Contains DI Package
10813079022609
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |