Duns Number:060398989
Device Description: Needle, Flexiguide without Female Luer Adaptor and Stylet with 90 degree bend, Series-15, Needle, Flexiguide without Female Luer Adaptor and Stylet with 90 degree bend, Series-15, 20 cm, 10 ea
Catalog Number
-
Brand Name
AOS Flexiguide Needle
Version/Model Number
NFW0001-009
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JAQ
Product Code Name
System, Applicator, Radionuclide, Remote-Controlled
Public Device Record Key
00fcf076-9de2-41a6-b0f9-fd221710ef4d
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
October 05, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |