Duns Number:002348191
Device Description: EZ-IO(R) 45mm Needle Set
Catalog Number
9079-VC-001
Brand Name
ARROW
Version/Model Number
IPN033766
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
K141117,K141117,K141117
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
393d5f78-69d3-4acd-983e-af0b5f2b3143
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
20816000011977
Quantity per Package
50
Contains DI Package
10816000011970
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |