Single-use Ureteral Access Sheath

GUDID 16970462546778

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Ureteral introduction sheath

• Primary Device ID: 16970462546778
• NIH Device Record Key: 4839848e-0323-40c8-b83c-9a8a67618546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use Ureteral Access Sheath
• Version Model Number: Y-10-50
• Company DUNS: 403655303
• Company Name: Shenzhen HugeMed Medical Technical Development 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970462546771 [Primary]
GS1	16970462546778 [Package]; Contains: 06970462546771; Package: BOX [1 Units]; Discontinued: 2025-07-23; Not in Commercial Distribution
GS1	26970462546775 [Package]; Package: CASE [10 Units]; Discontinued: 2025-07-23; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250695

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: 2025-07-31
• Device Publish Date: 2025-07-23

On-Brand Devices [Single-use Ureteral Access Sheath]

• 16970462546815: Y-12-50
• 16970462546808: Y-12-40
• 16970462546792: Y-11-50
• 16970462546778: Y-10-50
• 06970462546764: Y-10-40
• 06970462546757: Y-09-50
• 06970462546740: Y-09-40