Zebra Guidewire for Urinary Tract

Basic Information

• Brand Name: Zebra Guidewire for Urinary Tract
• Primary DI: 06976055232960
• Version / Model: UWM-38150S
• Catalog Number: SF.UB11.B05
• 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: e02ce975-a734-403c-b4bf-5299540be60f

Device Description

The product is divided into hydrophobic type and mixed type. The hydrophobic type guidewire consists of a nitinol core wire, a Polytetrafluoroethylene (PTFE) cladding (applied to the entire wire) with no coating on the surface and a soft tip containing a stainless steel spring; The mixed type guidewire consists of a nitinol core wire, a Polytetrafluoroethylene (PTFE) cladding (applied to the part except the distal end), and a polyurethane containing tungsten (PU) cladding with hydrophilic coating on the surface (applied to the prat of distal end 60mm).

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	16976055232967	GS1		5	In Commercial Distribution
Primary	06976055232960	GS1
Package	26976055232964	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