Duns Number:330926895
Device Description: The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or plac The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The hydrophobic extrusion reduces intravascular friction in devices such as catheters. The distal tip of the MRWire is marked with discrete ring markers for MRI and X-Ray visibility and comes in different configurations such as straight and angled. Guide wires are supplied sterile and non-pyrogenic. The MRWire’s diameter is 0.035” (0.89 mm).
Catalog Number
CV-G-18035A
Brand Name
MRWire Guidewire
Version/Model Number
Angled MR Wire
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K173423,K173423
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
33516685-7ed0-4f44-9e17-c68987f59736
Public Version Date
September 07, 2018
Public Version Number
1
DI Record Publish Date
August 07, 2018
Package DI Number
14251244500433
Quantity per Package
5
Contains DI Package
04251244500436
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugate
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 37 |