Single-Use Cystoscope

GUDID 16970462546280

Shenzhen HugeMed Medical Technical Development Co., Ltd.

Flexible video cystoscope, single-use

• Primary Device ID: 16970462546280
• NIH Device Record Key: fb471a32-af7b-4c8a-a32f-6a93008b2db6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single-Use Cystoscope
• Version Model Number: CY-M40H
• Company DUNS: 403655303
• Company Name: Shenzhen HugeMed Medical Technical Development 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	06970462546283 [Primary]
GS1	16970462546280 [Package]; Contains: 06970462546283; Package: CASE [10 Units]; Discontinued: 2024-06-11; Not in Commercial Distribution
GS1	26970462546287 [Package]; Contains: 06970462546283; Package: CASE [5 Units]; Discontinued: 2024-06-11; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231118

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: 2024-06-19
• Device Publish Date: 2024-06-11

On-Brand Devices [Single-Use Cystoscope]

• 16970462546280: CY-M40H
• 16970462546273: CY-M52H
• 16970462546266: CY-M32
• 16970462546259: CY-M40
• 16970462546242: CY-M50
• 16970462546235: CY-M52