MICROLYZER

Basic Information

• Brand Name: MICROLYZER
• Primary DI: 08681092003159
• Version / Model: BLADE-FILTER 600
• Catalog Number: BLD600
• Company Name: T-BIYOTEKNOLOJI LABORATUVAR ESTETIK MEDIKAL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI
• Labeler DUNS: 505280884
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-14
• Public Version: 1
• Public Version Date: 2019-05-22
• Public Version Status: New
• Public Device Record Key: 2473c42c-91b3-464f-b10b-38ea2f6dd859

Device Description

Single-use Blade-Filter to be used with Microlyzer Cartridge

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJT	Aspiration Tray	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36142	Aspiration tray, single-use	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08681092003159	GS1