CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSCARDIOVASCULAR AND VASCULAR G

Basic Information

• Brand Name: CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONSCARDIOVASCULAR AND VASCULAR G
• Primary DI: 00884908028027
• Version / Model: MC120
• Catalog Number: MC120
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-24
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 8a9edbb1-d355-411d-a6b7-c1afb58f5a19
• Distribution End Date: 2021-01-29

Device Description

0.038" (0.98MM) X 120CM0.038" (0 STRAIGHT FLEX GUIDEWIRESTRAIGHT WITH SHEATHWITH SHEATH

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQX	Wire, guide, catheter	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35094	Cardiac/peripheral vascular guidewire, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30884908028028	GS1	inner box	10	Not in Commercial Distribution	2021-01-29
Primary	00884908028027	GS1
Package	50884908028022	GS1	box	4	Not in Commercial Distribution	2021-01-29

Customer Contacts

• Phone: [phone]
• Email: [email protected]