YiGaoMed

GUDID 06937440443835

"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."

Zhejiang Yigao Medical Technology Co., Ltd.

Ureteral introduction sheath

• Primary Device ID: 06937440443835
• NIH Device Record Key: 79d06d69-3733-4f02-b932-de4e7062348b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YiGaoMed
• Version Model Number: AFS09040US
• Company DUNS: 705490017
• Company Name: Zhejiang Yigao Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06937440443835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250132

FDA Product Code

• FED: Endoscopic Access Overtube, Gastroenterology-Urology

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-07
• Device Publish Date: 2025-09-29