Guidewire

Basic Information

• Brand Name: Guidewire
• Primary DI: 00841268101203
• Version / Model: SGW-038-09
• Catalog Number: SGW-038-09
• Company Name: GALT MEDICAL CORP.
• Labeler DUNS: 943156836
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-03
• Public Version: 5
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: e9a329f0-89c4-4c8e-973b-83228587e6c0
• Distribution End Date: 2021-03-05

Device Description

Guidewire

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQX	Wire, Guide, Catheter	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58115	Peripheral vascular guidewire, manual	A long, thin 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20841268101207	GS1	Shipper Box	25	Not in Commercial Distribution	2021-03-05
Package	10841268101200	GS1	Shelf Box	5	Not in Commercial Distribution	2021-03-05
Primary	00841268101203	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021990	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.018	Inch