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
80256
Brand Name
Guidewire 0.025 6/270cm angled
Version/Model Number
80256
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
1958155a-47ca-4b71-b179-7ff452f94bc5
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
Package DI Number
07640142810735
Quantity per Package
5
Contains DI Package
07640142811305
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
REF80323 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 |