Duns Number:488489766
Device Description: The Rotarex™ S and Aspirex™ S Guidewire has a LubriSkin PTFE-coated nitinol core wire with The Rotarex™ S and Aspirex™ S Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated Tungsten tip coated with DSM ComfortCoat® hydrophilic coating. The guidewire is used to initially cross through the area to be treated. To be used with Straub Medical catheters.
Catalog Number
80235
Brand Name
Guidewire 0.018 4/320cm angled (Straub Medical®)
Version/Model Number
Version 1.0
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"
-
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
51d24f4f-b537-4cf5-81db-1e1442e52a77
Public Version Date
July 01, 2022
Public Version Number
6
DI Record Publish Date
January 31, 2020
Package DI Number
07640142811183
Quantity per Package
5
Contains DI Package
07640142810261
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
REF80322 Carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |