FDA.reportPublic FDA data

MRWire Guidewire

Primary DI
04251244500436
Brand
MRWire Guidewire
Company
Contract Medical International GmbH
Model
Angled MR Wire
Catalog number
CV-G-18035A
Device description
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).
Published
2018-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173423000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173423000MR Wire Guide Wire Straight, MR Wire Guide Wire AngledNano4imaging GmbH2017-11-17DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14251244500433PackageGS15In Commercial Distribution
04251244500436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425124450043314251244500433
04251244500436042512445004364251244500436

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length180Centimeter
Outer Diameter0.035Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4924156528261info@nano4imaging.com

Regulatory Flags#

DUNS number
330926895
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251244501983Catapult Guide Sheath4F, 45cm, straight, hydrophilic coatedUS-34045-F-ST-H2023-09-01
04251244501990Catapult Guide Sheath4F, 60cm, straight, hydrophilic coatedUS-34060-F-ST-H2023-09-01
04251244502003Catapult Guide Sheath4F, 90cm, straight, hydrophilic coatedUS-34090-F-ST-H2023-09-01
04251244502010Catapult Guide Sheath5F, 15cm, straight, hydrophilic coatedUS-35015-F-ST-H2023-09-01
04251244502027Catapult Guide Sheath5F, 45cm, straight, hydrophilic coatedUS-35045-F-ST-H2023-09-01
04251244502034Catapult Guide Sheath5F, 45cm, Multipurpose, hydrophilic coatedUS-35045-F-MP-H2023-09-01
04251244502041Catapult Guide Sheath5F, 45cm, RDC, hydrophilic coatedUS-35045-F-RDC-H2023-09-01
04251244502058Catapult Guide Sheath5F, 45cm, Hockey stick, hydrophilic coatedUS-35045-F-HS-H2023-09-01
04251244502065Catapult Guide Sheath5F, 60cm, straight, hydrophilic coatedUS-35060-F-ST-H2023-09-01
04251244502072Catapult Guide Sheath5F, 90cm, straight, hydrophilic coatedUS-35090-F-ST-H2023-09-01
04251244502089Catapult Guide Sheath6F, 15cm, straight, hydrophilic coatedUS-36015-F-ST-H2023-09-01
04251244502096Catapult Guide Sheath6F, 45cm, straight, hydrophilic coatedUS-36045-F-ST-H2023-09-01
04251244502102Catapult Guide Sheath6F, 45cm, Multipurpose, hydrophilic coatedUS-36045-F-MP-H2023-09-01
04251244502119Catapult Guide Sheath6F, 45cm, LIMA, hydrophilic coatedUS-36045-F-LIMA-H2023-09-01
04251244502126Catapult Guide Sheath6F, 45cm, RDC, hydrophilic coatedUS-36045-F-RDC-H2023-09-01
04251244502133Catapult Guide Sheath6F, 45cm, Hockey stick, hydrophilic coatedUS-36045-F-HS-H2023-09-01
04251244502140Catapult Guide Sheath6F, 60cm, straight, hydrophilic coatedUS-36060-F-ST-H2023-09-01
04251244502157Catapult Guide Sheath6F, 90cm, straight, hydrophilic coatedUS-36090-F-ST-H2023-09-01
04251244502164Catapult Guide Sheath6F, 90cm, Multipurpose, hydrophilic coatedUS-36090-F-MP-H2023-09-01
04251244502171Catapult Guide Sheath6F, 90cm, RDC, hydrophilic coatedUS-36090-F-RDC-H2023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00884450529348SplashWire™Merit Medical Systems, Inc.DQX2026-07-07
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