Single Use Video Ureteroscope Direct In-Scope Suction

GUDID 16971176282938

This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney. This instrument is also used as a suction catheter that establishes a conduit used for irrigation and aspiration of kidney stones and stone dust during ureteral lithotripsy. This instrument is labeled Reverse Deflection.

Zhuhai Pusen Medical Technology Co, Ltd

Flexible video ureteroscope, single-use

• Primary Device ID: 16971176282938
• NIH Device Record Key: a1441f9a-f6e9-430e-804d-49f5e5a9a070
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Video Ureteroscope Direct In-Scope Suction
• Version Model Number: PU630A-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	06971176282931 [Primary]
GS1	16971176282938 [Package]; Contains: 06971176282931; Package: carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233778

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: 2026-01-21
• Device Publish Date: 2026-01-13

On-Brand Devices [Single Use Video Ureteroscope Direct In-Scope Suction]

• 06971176282979: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176282969: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176282938: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc
• 16971176282921: This instrument has been designed to be used with Endo-Therapy accessories such as a biopsy forc