CoralView®

GUDID 16975339620346

CoralView®, Single-Use Digital Flexible Ureteroscope, U20-B

MacroLux Medical Technology Co., Ltd.

Flexible video ureteroscope, single-use

• Primary Device ID: 16975339620346
• NIH Device Record Key: 3c219cfe-5118-43ec-a83e-2f447fa01f7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoralView®
• Version Model Number: U20-B
• Company DUNS: 723490133
• Company Name: MacroLux 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: 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	06975339620349 [Primary]
GS1	16975339620346 [Package]; Contains: 06975339620349; Package: Box [5 Units]; In Commercial Distribution
GS1	26975339620343 [Package]; Package: Case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231774

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: 2024-04-05
• Device Publish Date: 2024-03-28

On-Brand Devices [CoralView®]

• 16975339620322: CoralView®, Single-Use Digital Flexible Ureteroscope, U10-BR
• 16975339620315: CoralView®, Single-Use Digital Flexible Ureteroscope, U10-B
• 06975339620301: CoralView®, Single-Use Digital Flexible Ureteroscope, U10
• 16975339620353: CoralView®, Single-Use Digital Flexible Ureteroscope, U20-BR
• 16975339620346: CoralView®, Single-Use Digital Flexible Ureteroscope, U20-B
• 16975339620339: CoralView®, Single-Use Digital Flexible Ureteroscope, U20