FDA.reportPublic FDA data

MICROLYZER FAT PROCESSOR 2400

Primary DI
08682754370008
Brand
MICROLYZER FAT PROCESSOR 2400
Company
T-BIYOTEKNOLOJI LABORATUVAR ESTETIK MEDIKAL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI
Model
MC 3101
Catalog number
MC 3101
Device description
MICROLYZER FAT PROCESSOR 2400
Published
2021-02-11
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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08682754370008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08682754370008086827543700088682754370008

GMDN Terms#

Term, Definition table
TermDefinition
Autologous adipose tissue collection/washing setA collection of sterile devices designed as a closed system for the harvesting and rapid treatment of autologous fat tissue for reinjection back into the patient from which it was taken for aesthetic body contouring. It typically consists of various chambers (e.g., a collection bag, waste material bag, and a cleaned tissue bag), flexible tubing, an intravenous (IV) spike for connection to the washing solutions, and a contiguous filter mesh which dialyses the fat graft. It is used in conjunction with appropriate IV solutions within the sterile field of intervention for plastic and reconstructive surgery and cosmetic surgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+902242468522info@tlab.com.tr

Regulatory Flags#

DUNS number
505280884
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
08682754370015MICROLYZER FAT PROCESSOR 1200MC 3102MC 31022021-02-11
08682754370022MICROLYZER Fat Processor 600MC 3103MC 31032021-02-11
08682754370039MICROLYZER Fat Processor 41MC 3104MC31042021-02-11
08681092003111Next PRPN500N5002019-02-05
08681092003067MICROLYZERCARTRIDGEMCR12019-05-14
08681092003135MICROLYZERBLADE-FILTER 2400BLD24002019-05-14
08681092003142MICROLYZERBLADE-FILTER 1200BLD12002019-05-14
08681092003159MICROLYZERBLADE-FILTER 600BLD6002019-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400477MillenniumAvalign Technologies, Inc.MDM2026-07-17
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00198506092381ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-17
B382SD9176201020Surgical DirectSurgical Direct, Inc.MDM2026-07-13
03661219436348LANDANGERLANDANGERMDM2026-07-12
00810158210615PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00810158215917PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713015PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713039PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713046PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
00850088713053PRINCETONPrinceton Medical Group, Inc.MDM2026-07-10
03661219436522LANDANGERLANDANGERMDM2026-07-08
03661219436584LANDANGERLANDANGERMDM2026-07-08
03661219436706LANDANGERLANDANGERMDM2026-07-08
04054462915583evonosevonos GmbH & Co. KGMDM2026-06-25
00198506091612ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00198506091629ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-24
00810158211179PRINCETONPrinceton Medical Group, Inc.MDM2026-06-23
00198506091353ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
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00198506091384ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091407ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-09
00198506091209ELMED INCORPORATEDELMED INCORPORATEDMDM2026-06-03
00810130456406Medco ManufacturingMedco Manufacturing LLCMDM2026-06-02
00846338007126Endiscope and accessoriesELLIQUENCE, LLCMDM2026-06-02
00846338005429DilatorELLIQUENCE, LLCMDM2026-06-01
06932503510219Pulmonary Hydro-Slide GuidewireMicro-Tech (Nanjing) Co., Ltd.MDM2026-05-29