ViewHub®

GUDID 16975339626164

ViewHub®, Video Processor, S13

MacroLux Medical Technology Co., Ltd.

Endoscopic video image processing unit

• Primary Device ID: 16975339626164
• NIH Device Record Key: be64ead2-6743-43d4-b8b5-b00642f81338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViewHub®
• Version Model Number: S13
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	06975339626167 [Primary]
GS1	16975339626164 [Package]; Contains: 06975339626167; Package: [1 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: false

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

Devices Manufactured by MacroLux Medical Technology Co., Ltd.

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• 16975339622265 - LoopView®: 2024-11-08 LoopView®, Single-Use Digital Flexible Bronchoscope, B58-C, multi-language
• 06975339623166 - SeleneView®: 2024-09-02 SeleneView®, Single-Use Digital Hysteroscope, HC29
• 16975339623170 - SeleneView®: 2024-09-02 SeleneView®, Single-Use Digital Hysteroscope, HC29-G
• 16975339623187 - SeleneView®: 2024-09-02 SeleneView®, Single-Use Digital Hysteroscope, HC35
• 16975339623194 - SeleneView®: 2024-09-02 SeleneView®, Single-Use Digital Hysteroscope, HC35-G
• 16975339623200 - SeleneView®: 2024-09-02 SeleneView®, Single-Use Digital Hysteroscope, HO35