Single-use Ureteral Access Sheath

GUDID 06972197482232

Hunan Vathin Medical Instrument Co., Ltd

Ureteral introduction sheath

• Primary Device ID: 06972197482232
• NIH Device Record Key: 644d3db9-34f1-4ef3-b207-2393475147aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use Ureteral Access Sheath
• Version Model Number: UA-S1801
• Company DUNS: 554484862
• Company Name: Hunan Vathin Medical Instrument 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	06972197482232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240167

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: 2024-11-12
• Device Publish Date: 2024-11-04

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

• 06972197482317: UA-S1D01
• 06972197482300: UA-S1D00
• 06972197482294: UA-S1C01
• 06972197482287: UA-S1C00
• 06972197482270: UA-S1B01
• 06972197482263: UA-S1B00
• 06972197482256: UA-S1A01
• 06972197482249: UA-S1A00
• 06972197482232: UA-S1801
• 06972197482225: UA-S1800