LiNA CystoVu™ HD

GUDID 05708265013944

LiNA CystoVu™ HD, Single-use Flexible Cystoscope, Standard Deflection

Lina Medical ApS

Flexible video cystoscope, single-use

• Primary Device ID: 05708265013944
• NIH Device Record Key: 4328226a-2da2-40c1-9676-d3fb4809dbc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LiNA CystoVu™ HD
• Version Model Number: CYV-100-5
• Company DUNS: 305088619
• Company Name: Lina Medical ApS
• 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: 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	05708265013944 [Primary]
GS1	05708265013951 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240227

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: 2024-10-01
• Device Publish Date: 2024-09-23

On-Brand Devices [LiNA CystoVu™ HD]

• 05708265013975: LiNA CystoVu™ HD, Single-use Flexible Cystoscope , Reverse Deflection
• 05708265013944: LiNA CystoVu™ HD, Single-use Flexible Cystoscope, Standard Deflection