Duns Number:788341084
Catalog Number
-
Brand Name
Phoenix 0.014” Guidewire, Floppy Tip / Light Support
Version/Model Number
PG14300LF
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
fe756b4a-7191-4684-bb00-09a958b100d8
Public Version Date
March 31, 2022
Public Version Number
5
DI Record Publish Date
September 01, 2016
Package DI Number
00845225002763
Quantity per Package
5
Contains DI Package
10845225002760
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 26 |