Single Use Flexible Video Cystoscope

GUDID 06971176280357

This device is a sterile, single use video cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Single Use Flexible Video Cystoscope is intended to provide visualization via video processor and can be used with endoscopic accessories.

Zhuhai Pusen Medical Technology Co, Ltd

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• Primary Device ID: 06971176280357
• NIH Device Record Key: 19188d85-78ab-4020-818e-4a9a5db4206b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Flexible Video Cystoscope
• Version Model Number: PC200-R
• Company DUNS: 544427443
• Company Name: Zhuhai Pusen Medical Technology Co, Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971176280357 [Primary]
GS1	16971176280354 [Package]; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222602

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: 2022-12-12
• Device Publish Date: 2022-12-02

On-Brand Devices [Single Use Flexible Video Cystoscope]

• 06971176280364: This device is a sterile, single use video cystoscope intended to be used for endoscopic access
• 06971176280357: This device is a sterile, single use video cystoscope intended to be used for endoscopic access
• 06971176280340: This device is a sterile, single use video cystoscope intended to be used for endoscopic access
• 06971176280333: This device is a sterile, single use video cystoscope intended to be used for endoscopic access