Single-Use Flexible Cystoscope

GUDID 06972197480382

Hunan Vathin Medical Instrument Co., Ltd

Flexible video cystoscope, single-use

• Primary Device ID: 06972197480382
• NIH Device Record Key: 9f1ea231-853e-4739-a262-f172066d99c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-Use Flexible Cystoscope
• Version Model Number: CY-S1E00
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972197480382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221580

FDA Product Code

• FAJ: Cystoscope 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: 2023-02-27
• Device Publish Date: 2023-02-17

On-Brand Devices [Single-Use Flexible Cystoscope]

• 06972197480474: CY-S1J01
• 06972197480450: CY-S1H01
• 06972197480443: CY-S1E01
• 06972197480436: CY-S1D01
• 06972197480429: CY-S1B01
• 06972197480412: CY-S1J00
• 06972197480399: CY-S1H00
• 06972197480382: CY-S1E00
• 06972197480375: CY-S1D00
• 06972197480368: CY-S1B00