FDA.reportPublic FDA data

LiNA OperåScope™ with HDMI cable & LCD

Primary DI
05708265010295
Brand
LiNA OperåScope™ with HDMI cable & LCD
Company
Lina Medical ApS
Model
OP‐201‐1
Catalog number
OP‐201‐1
Published
2018-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708265010295PackageGS11In Commercial Distribution
05708265010288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708265010295057082650102955708265010295
05708265010288057082650102885708265010288

GMDN Terms#

Term, Definition table
TermDefinition
Rigid video hysteroscopeA sterile battery-powered endoscope with a predominantly rigid inserted portion (which may have a flexible-tip) intended to allow visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endosocpe and the images showing on a monitor. It is commonly used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia) and bleeding between periods (metrorrhagia). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
305088619
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

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