MRWire Guidewire

Primary DI
04251244500429
Brand
MRWire Guidewire
Company
Contract Medical International GmbH
Model
Straight MR Wire
Catalog number
CV-G-18035S
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
14251244500426PackageGS15In Commercial Distribution
04251244500429PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1425124450042614251244500426
04251244500429042512445004294251244500429

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
04251244502768Catapult Guide Sheath4F, 130cm, Straight, hydrophilic coatedUS-34130-F-ST-H2024-08-19
04251244502775Catapult Guide Sheath5F, 130cm, Straight, hydrophilic coatedUS-35130-F-ST-H2024-08-19
04251244502782Catapult Guide Sheath6F, 130cm, Straight, hydrophilic coatedUS-36130-F-ST-H2024-08-19
14251244502765Catapult Guide Sheath4F, 130cm, Straight, hydrophilic coatedUS-34130-F-ST-H2024-08-19
14251244502772Catapult Guide Sheath5F, 130cm, Straight, hydrophilic coatedUS-35130-F-ST-H2024-08-19
14251244502789Catapult Guide Sheath6F, 130cm, Straight, hydrophilic coatedUS-36130-F-ST-H2024-08-19
04251244503604Biotronik Fortress Introducer Sheath System4F; 45 cm; straight3588142024-06-24
04251244503611Biotronik Fortress Introducer Sheath System4F; 100 cm; straight358815 2024-06-24
04251244503628Biotronik Fortress Introducer Sheath System4F; 45 cm; crossover358813 2024-06-24
04251244503635Biotronik Fortress Introducer Sheath System4F; 65 cm; straight444486 2024-06-24
04251244503642Biotronik Fortress Introducer Sheath System4F; 90 cm; straight4444852024-06-24
04251244503659Biotronik Fortress Introducer Sheath System5F; 45 cm; straight386591 2024-06-24
04251244503666Biotronik Fortress Introducer Sheath System5F; 100 cm; straight386592 2024-06-24
04251244503673Biotronik Fortress Introducer Sheath System5F; 45 cm; crossover3865902024-06-24
04251244503680Biotronik Fortress Introducer Sheath System5F; 65 cm; straight444484 2024-06-24
04251244503697Biotronik Fortress Introducer Sheath System5F; 90 cm; straight444483 2024-06-24
04251244503703Biotronik Fortress Introducer Sheath System6F; 45 cm; straight386594 2024-06-24
04251244503710Biotronik Fortress Introducer Sheath System6F; 100 cm; straight386595 2024-06-24
04251244503727Biotronik Fortress Introducer Sheath System6F; 45 cm; crossover386593 2024-06-24
04251244503734Biotronik Fortress Introducer Sheath System6F; 65 cm; straight444482 2024-06-24

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