M-Wire

Primary DI: 10816349010641
Brand: M-Wire
Company: Lake Region Medical
Model: LR1BG049
Published: 2016-09-24
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: true
Single use: true

Related Records

Product Codes

Code	Name
DQX	Wire, Guide, Catheter

Product Code Classifications

Code	Device	Specialty	Class
DQX	Wire, Guide, Catheter	Cardiovascular	2

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
10816349010641	Package	GS1	5	In Commercial Distribution
00816349010644	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
10816349010641	10816349010641
00816349010644	00816349010644	816349010644	0816349010644

GMDN Terms

Term	Definition
Peripheral vascular guidewire, manual	A long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Term

Definition

Peripheral vascular guidewire, manual

A long, thin, sterile wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes

Type	Value	Unit
Length	45	Centimeter
Outer Diameter	0.018	Inch

Storage And Handling

Type	Low	High	Condition
Special Storage Condition, Specify	0	0	Keep dry. Keep away from sunlight.

Sterilization Methods

Method

Regulatory Flags

DUNS number: 031108704
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: false
Combination product: false
Lot or batch: true
Serial number: false
Manufacturing date on label: true
Expiration date on label: true
Donation ID number: false
Contains natural rubber latex: false
No natural rubber latex: false
Sterilization required before use: false

Other Devices From This Company

Primary DI	Brand	Model	Catalog	Published
10816349013536	GuideRight	404569-1	404569-1	2026-03-24
10816349013543	GuideRight	404570-1	404570-1	2026-03-24
10816349013550	GuideRight	404578-1	404578-1	2026-03-24
10816349013567	GuideRight	404571-1	404571-1	2026-03-24
10816349013574	GuideRight	404577-1	404577-1	2026-03-24
10816349013581	GuideRight	404610-1	404610-1	2026-03-24
10816349013598	GuideRight	404617-1	404617-1	2026-03-24
10816349013604	GuideRight	404840-1	404840-1	2026-03-24
10816349013611	GuideRight	404843-1	404843-1	2026-03-24
10816349013628	GuideRight	404844-1	404844-1	2026-03-24
10816349013635	GuideRight	404878-1	404878-1	2026-03-24
10816349013642	GuideRight	404568-1	404568-1	2026-03-24
10816349013659	GuideRight	404555-1	404555-1	2026-03-24
10816349013666	GuideRight	404560-1	404560-1	2026-03-24
10816349015097	Intuition	IN32180J	ABFBF-007V	2026-01-06
10816349014861	PV-Tracker™	990045	ABFBF-003V	2025-02-12
08714729761761	ZIPwire™	M006630205B0	M006630205B0	2016-10-31
08714729761778	ZIPwire™	M006630206B0	M006630206B0	2016-10-31
08714729761785	ZIPwire™	M006630209B0	M006630209B0	2016-10-31
08714729761792	ZIPwire™	M006630223B0	M006630223B0	2016-10-31

Other Devices Sharing Product Codes

Primary DI	Brand	Company	Product code	Published
10816349013536	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013543	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013550	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013567	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013574	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013581	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013598	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013604	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013611	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013628	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013635	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013642	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013659	GuideRight	Lake Region Medical	DQX	2026-03-24
10816349013666	GuideRight	Lake Region Medical	DQX	2026-03-24
10884450529581	SplashWire™	Merit Medical Systems, Inc.	DQX	2026-03-24
20801902193418	ARROW	TELEFLEX INCORPORATED	DQX	2026-03-23
20801902221876	ARROW	TELEFLEX INCORPORATED	DQX	2026-03-13
20801902221883	ARROW	TELEFLEX INCORPORATED	DQX	2026-03-13
20801902221890	ARROW	TELEFLEX INCORPORATED	DQX	2026-03-13
20801902225522	ARROW	TELEFLEX INCORPORATED	DQX	2026-03-11
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16936733736644	ULTRASKIN	Lepu Medical Technology (Beijing) Co.,Ltd.	DQX	2026-02-27
16936733736651	ULTRASKIN	Lepu Medical Technology (Beijing) Co.,Ltd.	DQX	2026-02-27
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