FDA.reportPublic FDA data

Euromi

Primary DI
03701416200431
Brand
Euromi
Company
Euromi
Model
1214LVITW-5350
Catalog number
1214LVITW-5350
Device description
The cannulas are reusable medical devices intended to be used by healthcare professionals for surgical or aesthetic applications.They are designed for the injection, irrigation, or aspiration of biological fluids, depending on their configuration.Manufactured from stainless steel or tungsten, they provide excellent mechanical and chemical resistance, ensuring durability and compatibility with standard cleaning, disinfection, and sterilization processes commonly used in the medical field.The cannulas are supplied non-sterile and must be thoroughly cleaned and sterilized before each use.They are available in various lengths, diameters, and tip configurations depending on the intended use, and are designed to ensure precise, safe, and comfortable handling.
Published
2025-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEACannula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEACannula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010311000LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICEEuromi S.A2001-06-29QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701416200431PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701416200431037014162004313701416200431

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction system cannula, reusableA rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
505804302
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701416203401EUROMIEva sp6 - 110V 1114sp616110V 2025-08-27
03701416200066Euromi1214LMEW-42501214LMEW-42502025-10-10
03701416200110Euromi1214LMEI-52001214LMEI-52002025-10-10
03701416200134Euromi1214LMEW-53001214LMEW-53002025-10-10
03701416200172Euromi1214LMEI-52501214LMEI-52502025-10-10
03701416200233Euromi1214LMEW-43501214LMEW-43502025-10-10
03701416200776Euromi1214LMEI-43001214LMEI-43002025-10-10
03701416201339Euromi1214LVITI-52001214LVITI-52002025-10-10
03701416201377Euromi1214LMEW-43001214LMEW-43002025-10-10
03701416201421Euromi1214LMEW-52001214LMEW-52002025-10-10
03701416201445Euromi1214LMEW-41501214LMEW-41502025-10-10
03701416201643Euromi1214LVITW-4.52501214LVITW-4.52502025-10-10
03701416201650Euromi1214LVITW-4.53001214LVITW-4.53002025-10-10
03701416201711Euromi1214LMEI-53501214LMEI-53502025-10-10
03701416201889Euromi1214LMEW-52501214LMEW-52502025-10-10
03701416201964Euromi1214LMEW-53501214LMEW-53502025-10-10
03701416202015Euromi1214LVITW-4.52001214LVITW-4.52002025-10-10
03701416202022Euromi1214LVITW-4.53501214LVITW-4.53502025-10-10
03701416202046Euromi1214LMEI-53001214LMEI-53002025-10-10
03701416202084Euromi1214LMEW-42001214LMEW-42002025-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776403249MillenniumAvalign Technologies, Inc.GEA2026-07-19
00810220800485Adler Instrument CompanyAdler, Inc.GEA2026-07-17
10810128462782StayPort™ Cannula 5 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462799StayPort™ Cannula 5 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462805StayPort™ Cannula 7 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462812StayPort™ Cannula 7 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462829StayPort™ Cannula 9 mm x 7 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462836StayPort™ Cannula 9 mm x 9 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462843StayPort™ Cannula 9 mm x 11 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
10810128462850StayPort™ Cannula 9 mm x 13 cmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONGEA2026-07-16
B382SD2303290Surgical DirectSurgical Direct, Inc.GEA2026-07-14
B382SD303490Surgical DirectSurgical Direct, Inc.GEA2026-07-14
00810130456574Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456581Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456598Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456604Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
00810130456611Medco ManufacturingMedco Manufacturing LLCGEA2026-07-09
20192253036821MonojectCardinal Health 200, LLCGEA2026-07-09
00850083275709Intrace USAPILOTIS TECH LLCGEA2026-07-03
00810130456550Medco ManufacturingMedco Manufacturing LLCGEA2026-06-26
00810130456567Medco ManufacturingMedco Manufacturing LLCGEA2026-06-26
00840329838232BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
00840329838249BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GEA2026-06-08
G4533312250PEAK MEDICALPeak Medical Distribution Inc.GEA2026-06-08
00810130456420Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456437Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456444Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456451Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456468Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05
00810130456475Medco ManufacturingMedco Manufacturing LLCGEA2026-06-05