Single-use Ureteral Access Sheath

Basic Information

• Brand Name: Single-use Ureteral Access Sheath
• Primary DI: 06972197483468
• Version / Model: UA-S1B02
• Company Name: Hunan Vathin Medical Instrument Co., Ltd
• Labeler DUNS: 554484862
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-08
• Public Version: 3
• Public Version Date: 2026-04-15
• Public Version Status: Update
• Public Device Record Key: 91fd5f7c-4d26-439e-a2bd-4c8b3c1e29c9

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

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	06972197483468	GS1
Package	16972197483465	GS1	Intermediate Package	1	In Commercial Distribution
Package	56972197483463	GS1	Shipping Package	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K250785	000
K251599	000