Duns Number:002348191
Device Description: Percutaneous Cavity Drainage Catheterization Kit Seldinger Insertion Technique
Catalog Number
AK-01600
Brand Name
ARROW
Version/Model Number
IPN036836
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
K895516,K895516
Product Code
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
f5a0a1c5-4839-4500-a00d-7266aa7fb8ee
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
Package DI Number
40801902120159
Quantity per Package
5
Contains DI Package
10801902120158
Package Discontinue Date
November 13, 2017
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 |