FDA.reportPublic FDA data

LiNA ScopeVu™

Primary DI
05708265014002
Brand
LiNA ScopeVu™
Company
Lina Medical ApS
Model
SCP-100-1
Device description
LiNA ScopeVu™ Full HD display and light source
Published
2024-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240227000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240227000LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps2024-08-22FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708265014019PackageGS11In Commercial Distribution
05708265014002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708265014019057082650140195708265014019
05708265014002057082650140025708265014002

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing/light source systemA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305088619
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708265000241EpiGuard81702023-06-07
05708265000890Drain Guard81502023-06-07
05708265005109Pleura-Guard81612023-06-07
05708265014095LiNA CystoVu™ HD Biopsy Forceps CYV-FCP-5 2025-04-18
05708265014118LiNA CystoVu™ HD GrasperCYV-GRA-52025-04-18
05708265014101LiNA CystoVu™ HD Biopsy Forceps CYV-FCP-5 2025-04-18
05708265014125LiNA CystoVu™ HD GrasperCYV-GRA-52025-04-18
05708265012442LiNA OperaScope™ Biopsy ForcepsOP-FCP-6OP-FCP-62020-08-03
05708265012466LiNA OperaScope™ Rat Tooth Alligator GrasperOP-GRA-6OP-GRA-62020-09-04
05708265013319LiNA Xcise™, Laparoscopic MorcellatorMOR-1515-1MOR-1515-12024-09-24
05708265013326LiNA Xcise™, Laparoscopic MorcellatorMOR-1515-1MOR-1515-12024-09-24
05708265013333LiNA Xcise™, Laparoscopic MorcellatorMOR-1515-6MOR-1515-62024-09-23
05708265013968LiNA CystoVu™ HDCYV-101-52024-09-23
05708265013340LiNA Xcise™, Laparoscopic MorcellatorMOR-1515-6MOR-1515-62024-09-23
05708265013944LiNA CystoVu™ HDCYV-100-52024-09-23
05708265013975LiNA CystoVu™ HDCYV-101-52024-09-23
05708265004508LiNA Xcise™, Laparoscopic MorcellatorMOR-1515-1MOR-1515-12016-09-15
05708265010219LiNA OperaScope™ Rat Tooth Alligator GrasperOP-GRA-6OP-GRA-62018-04-11
05708265010301LiNA OperåScope™ with HDMI cable & LCD OP-201-6OP-201-62018-02-21
05708265010943LiNA OperåScope™ with HDMI cable & LCD OP-201-6OP-201-62018-11-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
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06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
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