YiGaoMed

Basic Information

• Brand Name: YiGaoMed
• Primary DI: 06937440443835
• Version / Model: AFS09040US
• Catalog Number: SYUAS-9-40
• Company Name: Zhejiang Yigao Medical Technology Co., Ltd.
• Labeler DUNS: 705490017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-29
• Public Version: 2
• Public Version Date: 2025-12-10
• Public Version Status: Update
• Public Device Record Key: 79d06d69-3733-4f02-b932-de4e7062348b

Device Description

"The Ureteral Access Sheath consist of an outer sheath, a tapered dilator and their sockets. The hydrophilic coating are applied to the sheath and the tip of dialtor. The ureteral access sheath is used to establish a working channel during endoscopic urological procedures, facilitating the passage of endoscopes and other instruments into the urinary tract. This is a single-use device. A re-sterilization by users and re-use of the device are not allowed."

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64309	Ureteral introduction sheath	A flexible tube intended to be used for ureteral access to allow introduction of other instruments (e.g., endoscope, catheter) and/or for guidewire exchange during a urological procedure. It may be intended for ureteral access via transurethral and/or percutaneous approach, and typically includes an inner dilator; it is however not a full introduction set. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06937440443835	GS1

Premarket Submissions

Submission Number	Supplement Number
K250132	000