Single-use Flexible Ureteroscope

GUDID 06972197480597

Hunan Vathin Medical Instrument Co., Ltd

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• Primary Device ID: 06972197480597
• NIH Device Record Key: cb1b21a3-54c5-4b6b-9855-03701412dd75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-use Flexible Ureteroscope
• Version Model Number: US-S2600
• 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	06972197480597 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231135

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: 2024-02-05
• Device Publish Date: 2024-01-28

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