Duns Number:002348191
Device Description: Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 8 - 8.5 Fr. Catheters
Catalog Number
ASK-09903-HH1
Brand Name
ARROW
Version/Model Number
IPN034488
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K780532,K780532
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
79dfffe4-ae8a-4db8-bfe4-ab289d534762
Public Version Date
February 19, 2021
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
30801902092527
Quantity per Package
5
Contains DI Package
00801902092526
Package Discontinue Date
April 05, 2018
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |