FDA.reportPublic FDA data

LipiVage®

Primary DI
00818257020012
Brand
LipiVage®
Company
GENESIS BIOSYSTEMS, INC.
Model
D11-0290-108
Device description
LipiVage Harvester
Published
2017-04-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MUUSystem, Suction, Lipoplasty
QKLLipoaspirate Washing System For Aesthetic Body Contouring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2
QKLLipoaspirate Washing System For Aesthetic Body ContouringGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818257020012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818257020012008182570200128182570200120818257020012

GMDN Terms#

Term, Definition table
TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
972-315-7888customerservice@genesisbiosystems.com

Regulatory Flags#

DUNS number
067933700
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818257022122Derma Genesis InfusionD11-0358-101D11-0358-1012023-07-24
00818257020029LipiVage®D11-0290-1092017-04-21
00818257020074CoolBreezeD11-0318-5032017-04-21
00818257020081CoolBreezeD11-0318-5042017-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08681877009017Lipocube NanoSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009086Centrifgue Container (15CC)STEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009093Centrifgue Container (20 CC) STEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009116Lipocube HybridSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009345Lipocube Hybrid ISTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
08681877009826Lipocube Hybrid MiniSTEMC BIYOTEKNOLOJI ANONIM SIRKETIQKL2026-05-08
00810130455843Medco ManufacturingMedco Manufacturing LLCMUU2026-03-31
00850034511047Puregraft SYNCBimini Technologies LLCQKL2026-02-24
08800052308909FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
00850034511023Puregraft 850 System Twin PackBimini Technologies LLCQKL2024-08-22
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGMUU2024-05-31
07612367003551Quiver 280mmMedela AGMUU2024-05-31
07612367003568Quiver 480mmMedela AGMUU2024-05-31
07612367003698Overflow protection deviceMedela AGMUU2024-05-31
07612367003735Reusable serial connectorMedela AGMUU2024-05-31
07612367003742Safety Set for railholderMedela AGMUU2024-05-31
07612367003896Tubing holder left sideMedela AGMUU2024-05-31
07612367003902Tubing holder right sideMedela AGMUU2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGMUU2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGMUU2024-05-31
07612367004695Holder for 1L/1.5L jar, rightMedela AGMUU2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGMUU2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGMUU2024-05-31
07612367008242Double conical coupling pieceMedela AGMUU2024-05-31
07612367008655Silicone tube, ID 7mm, 33cmMedela AGMUU2024-05-31
07612367009928Y-pieceMedela AGMUU2024-05-31
07612367011204Vario Filter set, bacteria & overflowMedela AGMUU2024-05-31
07612367011372Single set 1lMedela AGMUU2024-05-31
07612367011389Single set 2lMedela AGMUU2024-05-31
07612367017329Single set 1l, clampholderMedela AGMUU2024-05-31