FDA.reportPublic FDA data

LiNA OperåScope™ with HDMI cable & LCD

Primary DI
05708265018192
Brand
LiNA OperåScope™ with HDMI cable & LCD
Company
LiNA Medical AG
Model
OP-201-6
Published
2026-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
05708265018208PackageGS16In Commercial Distribution
05708265018192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708265018208057082650182085708265018208
05708265018192057082650181925708265018192

GMDN Terms#

Term, Definition table
TermDefinition
Rigid video hysteroscopeAn electrically-powered endoscope with a rigid inserted portion (which may have a flexible-tip) intended for visual examination and treatment of the cervix canal and uterine cavity (uterus), or for removal of an early or non-viable embryo/foetus upon connection to an abortion suction system. It is inserted through the vagina during hysteroscopy; some types are also intended for insertion into the female urethra during cystoscopy. An image sensor chip at the distal end of the device transmits the video images to a display monitor. It is commonly used to evaluate/treat fibroids (myomas), polyps, or conditions related to the menstrual period (e.g., menorrhagia). This is a single-use device.

Regulatory Flags#

DUNS number
485705870
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
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
00848657078450AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-22
00810143893137Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893144Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893151Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893168Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893175Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893182Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893199Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893205Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893212Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893229Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893236Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893243Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893250Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893267Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893274Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893281Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893298Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893304Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00810143893311Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-21
00848657076609AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076616AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657076623AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078412AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078429AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078436AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657078443AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085656AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00848657085663AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.FAJ2026-07-21
00810143893007Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.FAJ2026-07-20