LiNA ScopeVu™

GUDID 05708265014002

LiNA ScopeVu™ Full HD display and light source

Lina Medical ApS

Endoscopic video image processing/light source system

• Primary Device ID: 05708265014002
• NIH Device Record Key: 5e39bb02-8128-4adb-83eb-ba811efeeb37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LiNA ScopeVu™
• Version Model Number: SCP-100-1
• 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: false
• 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	05708265014002 [Primary]
GS1	05708265014019 [Package]; Package: [1 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: false

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

Devices Manufactured by Lina Medical ApS

• 05708265014101 - LiNA CystoVu™ HD Biopsy Forceps: 2025-04-28 6.9 Fr Biopsy Forceps
• 05708265014125 - LiNA CystoVu™ HD Grasper: 2025-04-28 5.4 Fr Rath Tooth Alligator Grasper
• 05708265013326 - LiNA Xcise™, Laparoscopic Morcellator: 2024-10-02 15mm battery powered morcellator system with obturator
• 05708265013340 - LiNA Xcise™, Laparoscopic Morcellator: 2024-10-01 15mm battery powered morcellator system with obturator
• 05708265013944 - LiNA CystoVu™ HD: 2024-10-01 LiNA CystoVu™ HD, Single-use Flexible Cystoscope, Standard Deflection
• 05708265013975 - LiNA CystoVu™ HD: 2024-10-01 LiNA CystoVu™ HD, Single-use Flexible Cystoscope , Reverse Deflection
• 05708265014002 - LiNA ScopeVu™: 2024-10-01LiNA ScopeVu™ Full HD display and light source
• 05708265014002 - LiNA ScopeVu™: 2024-10-01 LiNA ScopeVu™ Full HD display and light source
• 05708265011537 - LiNA OperaScopeTM Lasso: 2024-09-27 LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.