FDA.reportPublic FDA data

LiNA Xcise™, Laparoscopic Morcellator

Primary DI
05708265015153
Brand
LiNA Xcise™, Laparoscopic Morcellator
Company
LiNA Medical AG
Model
MOR-1515-1
Device description
15 mm battery powered morcellator system with obturator
Published
2026-04-02
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
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708265015160PackageGS11In Commercial Distribution
05708265018321PackageGS112In Commercial Distribution
05708265015153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708265015160057082650151605708265015160
05708265018321057082650183215708265018321
05708265015153057082650151535708265015153

GMDN Terms#

Term, Definition table
TermDefinition
Tissue morcellation system handpiece, battery-poweredA battery-powered, hand-held device intended to be used to mechanically cut (slice), core (cut a hole into), peel (remove surface), and extract selected tissue from the body during surgery (e.g., prostate tissue morcellation during laparoscopy). It consists of a cordless instrument with a high-speed rotating blade in a holder. Resected tissue may be removed through suction or manually with a grasping instrument. 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

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