Ureteral Access Sheath

Basic Information

• Brand Name: Ureteral Access Sheath
• Primary DI: 06944932787650
• Version / Model: U03B011035
• Company Name: Well Lead Medical Co.,Ltd
• Labeler DUNS: 544811862
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-23
• Public Version: 1
• Public Version Date: 2024-05-01
• Public Version Status: New
• Public Device Record Key: 6849992c-89f7-41c9-aab9-309a8334efe3

Device Description

10Fr×35cm

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: 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
Package	16944932787657	GS1	Box	5	In Commercial Distribution
Primary	06944932787650	GS1
Package	26944932787654	GS1	Carton	10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K151084	000