FDA.reportPublic FDA data

LiNA CystoVu™ HD Grasper

Primary DI
05708265014125
Brand
LiNA CystoVu™ HD Grasper
Company
Lina Medical ApS
Model
CYV-GRA-5
Device description
5.4 Fr Rath Tooth Alligator Grasper
Published
2025-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTSEndoscopic Grasping/Cutting Instrument, Non-Powered, ExemptGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708265014125PackageGS15In Commercial Distribution
05708265014149PackageGS13In Commercial Distribution
05708265014118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708265014125057082650141255708265014125
05708265014149057082650141495708265014149
05708265014118057082650141185708265014118

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic tissue manipulation forceps, single-useA flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
305088619
Device count
1
DM exempt
false
Premarket exempt
true
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
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
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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