FDA.reportPublic FDA data

MICROLYZER

Primary DI
08681092003135
Brand
MICROLYZER
Company
T-BIYOTEKNOLOJI LABORATUVAR ESTETIK MEDIKAL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI
Model
BLADE-FILTER 2400
Catalog number
BLD2400
Device description
Single-use Blade-Filter to be used with Microlyzer Cartridge
Published
2019-05-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OJTAspiration Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJTAspiration TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08681092003135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08681092003135086810920031358681092003135

GMDN Terms#

Term, Definition table
TermDefinition
Aspiration tray, single-useA container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
505280884
Device count
1
Premarket exempt
true
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
08682754370008MICROLYZER FAT PROCESSOR 2400MC 3101MC 31012021-02-11
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
08681092003142MICROLYZERBLADE-FILTER 1200BLD12002019-05-14
08681092003159MICROLYZERBLADE-FILTER 600BLD6002019-05-14

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Primary DI, Brand, Company table
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