VISIGLIDE2

Basic Information

• Brand Name: VISIGLIDE2
• Primary DI: 04953170358265
• Version / Model: G-260-3545A
• Catalog Number: G-260-3545A
• Company Name: TERUMO CORPORATION
• Labeler DUNS: 690543319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 4
• Public Version Date: 2022-07-14
• Public Version Status: Update
• Public Device Record Key: 65de879b-66cf-4f6d-a5bc-a273afa61335

Device Description

VISIGLIDE2 Single Use 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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
OCY	Endoscopic guidewire, gastroenterology-urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46691	Gastro-urological guidewire, single-use	A sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	54953170358260	GS1	Carton	5	In Commercial Distribution
Primary	04953170358265	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Adaptable type : 0.035 inch
Length	4500	Millimeter
Device Size Text, specify			Hydrophilic Coating Length : 70mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 7.