Single-Use Flexible Cystoscope

GUDID 06972197483215

Hunan Vathin Medical Instrument Co., Ltd

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• Primary Device ID: 06972197483215
• NIH Device Record Key: c9962854-961c-42f8-8cd2-1c23393f28ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-Use Flexible Cystoscope
• Version Model Number: CY-S1D01R
• 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	06972197483215 [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: 2024-01-31
• Device Publish Date: 2024-01-23

On-Brand Devices [ Single-Use Flexible Cystoscope]

• 06972197483215: CY-S1D01R
• 06972197483208: CY-S1J01R
• 06972197483192: CY-S1H01R
• 06972197483185: CY-S1E01R
• 06972197483178: CY-S1B01R
• 06972197483109: CY-S1D00R
• 06972197483093: CY-S1J00R
• 06972197483086: CY-S1H00R
• 06972197483079: CY-S1E00R
• 06972197483062: CY-S1B00R