Duns Number:002348191
Device Description: Echogenic Introducer Needle
Catalog Number
AN-04318
Brand Name
ARROW
Version/Model Number
IPN925156
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
K071998,K071998,K071998
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
abbb48c9-ad60-4a94-b165-c58bdd0516ef
Public Version Date
August 04, 2022
Public Version Number
1
DI Record Publish Date
July 27, 2022
Package DI Number
30801902211249
Quantity per Package
25
Contains DI Package
10801902211245
Package Discontinue Date
-
Package Status
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 |