LiNA ScopeVu™

Basic Information

• Brand Name: LiNA ScopeVu™
• Primary DI: 05708265014002
• Version / Model: SCP-100-1
• Company Name: Lina Medical ApS
• Labeler DUNS: 305088619
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-23
• Public Version: 1
• Public Version Date: 2024-10-01
• Public Version Status: New
• Public Device Record Key: 5e39bb02-8128-4adb-83eb-ba811efeeb37

Device Description

LiNA ScopeVu™ Full HD display and light source

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34540	Endoscopic video image processing/light source system	A mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05708265014002	GS1
Package	05708265014019	GS1		1	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K240227	000