Ascend™ Single-Use Flexible Cysto-Nephroscope HD

GUDID 06972520302893

Guangzhou Red Pine Medical Instrument Co., Ltd.

Flexible video cystonephroscope, single-use

• Primary Device ID: 06972520302893
• NIH Device Record Key: 0cbbf359-262f-4ebb-b10a-80e81a7939fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascend™ Single-Use Flexible Cysto-Nephroscope HD
• Version Model Number: ASUS-HD-15R-CYS
• Company DUNS: 417649868
• Company Name: Guangzhou Red Pine Medical Instrument 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• 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	06972520302893 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K252176

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: 2026-01-08
• Device Publish Date: 2025-12-31

On-Brand Devices [Ascend™ Single-Use Flexible Cysto-Nephroscope HD]

• 06972520302909: ASUS-HD-15S-CYS
• 06972520302893: ASUS-HD-15R-CYS