Ureteral Access Sheath

GUDID 16936881134361

14Fr×20cm

Well Lead Medical Co.,Ltd

Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath Ureteral introduction sheath

• Primary Device ID: 16936881134361
• NIH Device Record Key: d71d88fa-2c20-494a-895e-d47e942447b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ureteral Access Sheath
• Version Model Number: U03B011420
• Company DUNS: 544811862
• Company Name: Well Lead Medical 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936881134364 [Primary]
GS1	16936881134361 [Package]; Contains: 06936881134364; Package: Box [5 Units]; In Commercial Distribution
GS1	26936881134368 [Package]; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151084

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: 2024-05-01
• Device Publish Date: 2024-04-23

On-Brand Devices [Ureteral Access Sheath]

• 16944932787688: 12Fr×35cm
• 16944932787671: 10Fr×45cm
• 16944932787664: 14Fr×35cm
• 16944932787657: 10Fr×35cm
• 16936881134408: 14Fr×55cm
• 16936881134392: 14Fr×45cm
• 16936881134378: 14Fr×28cm
• 16936881134361: 14Fr×20cm
• 16936881134354: 14Fr×13cm
• 16936881134347: 12Fr×55cm
• 16936881134330: 12Fr×45cm
• 16936881134316: 12Fr×28cm
• 16936881134309: 12Fr×20cm
• 16936881134293: 12Fr×13cm
• 16936881134286: 10Fr×55cm
• 16936881134255: 10Fr×28cm
• 16936881134248: 10Fr×20cm
• 16936881134231: 10Fr×13cm