Duns Number:002348191
Device Description: Single-Lumen Infusion Catheter (SLIC(R)) for use with Arrow Percutaneous Sheath Introducer Single-Lumen Infusion Catheter (SLIC(R)) for use with Arrow Percutaneous Sheath Introducer System
Catalog Number
SC-14701
Brand Name
ARROW
Version/Model Number
IPN036256
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K781846,K781846
Product Code
KGZ
Product Code Name
ACCESSORIES, CATHETER
Public Device Record Key
a2e7ba9d-d7c4-4584-8c79-7e73c834b978
Public Version Date
September 13, 2021
Public Version Number
6
DI Record Publish Date
September 16, 2016
Package DI Number
40801902121231
Quantity per Package
25
Contains DI Package
10801902121230
Package Discontinue Date
September 09, 2021
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 |