YiGaoMed SYUAS-11-50

GUDID 06937440443880

Zhejiang Yigao Medical Technology Co., Ltd.

Ureteral introduction sheath

• Primary Device ID: 06937440443880
• NIH Device Record Key: 556533f9-2746-4910-bce8-927f5151562f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YiGaoMed
• Version Model Number: AFS11050US
• Catalog Number: SYUAS-11-50
• 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	06937440443880 [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: 2025-12-17
• Device Publish Date: 2025-12-09

On-Brand Devices [YiGaoMed]

• 06937440443835: "The Ureteral Access Sheath consist of an outer sheath, a tapered dilator and their sockets. The
• 06937440443903: AFS12050US
• 06937440443897: AFS12040US
• 06937440443880: AFS11050US
• 06937440443873: AFS11040US
• 06937440443866: AFS10050US
• 06937440443859: AFS10040US
• 06937440443842: AFS09050US
• 06937440443828: DB180US
• 06937440443811: DB050US