FDA.reportPublic FDA data

LiNA OperaScope™ Scissors

Primary DI
05708265011490
Brand
LiNA OperaScope™ Scissors
Company
Lina Medical ApS
Model
OP-SCI-3
Catalog number
OP-SCI-3
Device description
Scissors for hysteroscopy.
Published
2019-06-28
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NWWHysteroscope Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWWHysteroscope AccessoriesObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708265011506PackageGS13In Commercial Distribution
05708265011490PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708265011506057082650115065708265011506
05708265011490057082650114905708265011490

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic scissors, single-useA sterile, rigid surgical instrument designed to be introduced through an endoscope (e.g., laparoscope, hysteroscope) or laparoscopic port, to mechanically cut tissues during an endoscopic/laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles, a long slender shaft, and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., straight scissor, bend scissor) controlled by a knob at the handle; it is not an electrosurgical device. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+48 612222149info.poland@lina-medical.com

Regulatory Flags#

DUNS number
305088619
Device count
1
Premarket exempt
true
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
05708265014002LiNA ScopeVu™ SCP-100-12024-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974880994343Omni® Hysteroscopic GrasperSuzhou AcuVu medical technology Co., Ltd.NWW2026-04-17
00190776420208MillenniumAvalign Technologies, Inc.NWW2026-04-16
05708265017881LiNA OperaScope™ Lasso LiNA Medical AGNWW2026-04-03
05708265017904LiNA OperaScopeTM LassoLiNA Medical AGNWW2026-04-03
05708265017928LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017942LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017980LiNA OperaScope™ ScissorsLiNA Medical AGNWW2026-04-03
00190776416379MillenniumAvalign Technologies, Inc.NWW2026-02-16
00850033976359HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
10850033976356HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
00198506087943ELMED INCORPORATEDELMED INCORPORATEDNWW2026-01-16
00190776410872MillenniumAvalign Technologies, Inc.NWW2025-09-15
00190776410544MillenniumAvalign Technologies, Inc.NWW2025-09-11
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