Single-use Flexible Ureteroscope

GUDID 06972197483048

Hunan Vathin Medical Instrument Co., Ltd

Flexible video ureteroscope, single-use

• Primary Device ID: 06972197483048
• NIH Device Record Key: c7b19b3c-02ea-4aeb-8673-4ab7a68065a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use Flexible Ureteroscope
• Version Model Number: US-S170R
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	06972197483048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230200

FDA Product Code

• FGB: Ureteroscope And Accessories, Flexible/Rigid

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: 2024-01-31
• Device Publish Date: 2024-01-23

On-Brand Devices [Single-use Flexible Ureteroscope]

• 06972197483055: US-E170R
• 06972197483048: US-S170R
• 06972197480689: US-E180
• 06972197480672: US-S180
• 06972197480665: US-S170
• 06972197480504: US-E170
• 06972197480603: US-E2600
• 06972197480597: US-S2600
• 06972197483130: US-E2600R
• 06972197483123: US-S2600R