Duns Number:002348191
Device Description: EZ-Stabilizer
Catalog Number
9066-VC-005
Brand Name
ARROW
Version/Model Number
IPN033748
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
KMK
Product Code Name
DEVICE, INTRAVASCULAR CATHETER SECUREMENT
Public Device Record Key
6d0274bc-be06-42d5-ab38-2e2b670dff4d
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
June 18, 2020
Package DI Number
20816000012554
Quantity per Package
5
Contains DI Package
10816000012557
Package Discontinue Date
February 02, 2022
Package Status
Not in Commercial Distribution
Package Type
Box
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 |