CoralView®

GUDID 06975339620301

CoralView®, Single-Use Digital Flexible Ureteroscope, U10

MacroLux Medical Technology Co., Ltd.

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• Primary Device ID: 06975339620301
• NIH Device Record Key: c6f24c22-a314-4c10-94c2-36019830f79d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoralView®
• Version Model Number: U10
• 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: true
• 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	06975339620301 [Primary]
GS1	16975339620308 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	26975339620305 [Package]; Contains: 16975339620308; 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: 2024-03-20
• Device Publish Date: 2024-03-12

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