Hydrophilic Guidewire for Urinary Tract

Basic Information

• Brand Name: Hydrophilic Guidewire for Urinary Tract
• Primary DI: 06976055232717
• Version / Model: UIW-18150A
• Catalog Number: SF.UA11.B04
• Company Name: SHENZHEN HAINWISE MEDICAL TECHNOLOGY CO., LTD.
• Labeler DUNS: 618556012
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-23
• Public Version: 2
• Public Version Date: 2024-12-23
• Public Version Status: Update
• Public Device Record Key: 6a734d60-a963-463a-8fb5-26e50a3218b8

Device Description

The guidewire consists of a core wire and a cladding, the core wire is made of nitinol. The cladding is made of polyurethane (tungsten impregnated), and the coating is coated with polyvinyl pyrrolidone hydrophilic coating.

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: Yes
• 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 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	16976055232714	GS1		5	In Commercial Distribution
Primary	06976055232717	GS1
Package	26976055232711	GS1		20	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius