FDA.reportPublic FDA data

LiNA OperåScope™ Recording Module

Primary DI
05708265018215
Brand
LiNA OperåScope™ Recording Module
Company
LiNA Medical AG
Model
OP-RM-1
Published
2026-04-03
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
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708265018215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708265018215057082650182155708265018215

GMDN Terms#

Term, Definition table
TermDefinition
Medical video image recorderAn electrically-powered device designed to be used in conjunction with video endoscopes, radiological equipment, and/or surgical video imaging devices (e.g., surgical microscope, camera) to digitally record video images for subsequent playback; it is not intended for distribution/routing of image data within a network (i.e., not a medical image management system). It is typically a portable device that may incorporate a small screen intended only to reference image capture.

Regulatory Flags#

DUNS number
485705870
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708265015306Drain Guard81502026-04-02
05708265015337EpiGuard81702026-04-02
05708265015368Pleura-Guard81612026-04-03
05708265015566LiNA PowerBlade™ 5005-E2026-04-03
05708265015627LiNA PowerBlade™ 5005-E-C2026-04-03
05708265015658LiNA PowerBlade™ 5005-E-C-1602026-04-03
05708265015801LiNA PowerBlade™ 5010-E2026-04-03
05708265015832LiNA PowerBlade™ 5010-E-1602026-04-03
05708265017201LiNA Skin Hook™SH-1102026-04-03
05708265017225LiNA Skin Hook™SH-1202026-04-03
05708265017249LiNA Skin Hook™SH-1302026-04-03
05708265017263LiNA Skin Hook™SH-2202026-04-03
05708265017300LiNA SeaStar™4000-S-Q2026-04-03
05708265017324LiNA SeaStar™4000-S-SL2026-04-03
05708265017348LiNA SeaStar™4000-S-SS2026-04-03
05708265017362LiNA SeaStar™4000-S-VL2026-04-03
05708265017386LiNA SeaStar™4000-S-VS2026-04-03
05708265017409LiNA SeaStar™4000-S-VV2026-04-03
05708265017706LiNA OperaScope™ Biopsy ForcepsOP-FCP-62026-04-03
05708265017744LiNA OperaScope™ Rat Tooth Alligator GrasperOP-GRA-62026-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826926952PENTAX MedicalPENTAX MEDICAL CORPORATIONFAJ2026-08-25
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
00850023925442WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925459WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925466WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925473WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925558WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925565WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925572WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925589WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925596WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925909WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925916WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925923WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925930WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925954WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925985WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925992WiScope®Otu Medical Inc.FAJ2026-07-28
06972084140498WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140504WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140511WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140528WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140597WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28