T-BIYOTEKNOLOJI LABORATUVAR ESTETIK MEDIKAL KOZMETIK SANAYI VE TICARET LIMITED SIRKETI

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Aspiration Tray (OJT) (4) Instrument, Manual, Surgical, General Use (MDM) (4) Syringe, Piston (FMF) (1)

Premarket Exempt

Yes

Clear

MICROLYZER - 08681092003067 Catalog Number : MCR1

Device Description : Re-usable Microlyzer Cartridge to be used with Microlyzer Blade-Filter 2400, Mic Re-usable Microlyzer Cartridge to be used with Microlyzer Blade-Filter 2400, Microlyzer Blade-Filter 1200 and Microlyzer Blade-Filter 600.

Device Class : 1

Duns Number: 505280884

Premarket Exempt : Yes

Product Code : OJT

Prescription Use : Yes

Device Count : 1

Next PRP - 08681092003111 Catalog Number : N500

Device Description : Next PRP Syringe

Device Class : 2

Duns Number: 505280884

Premarket Exempt : Yes

Product Code : FMF

Prescription Use : Yes

Device Count : 1

MICROLYZER - 08681092003135 Catalog Number : BLD2400

Device Description : Single-use Blade-Filter to be used with Microlyzer Cartridge

Device Class : 1

Duns Number: 505280884

Premarket Exempt : Yes

Product Code : OJT

Prescription Use : Yes

Device Count : 1

MICROLYZER - 08681092003142 Catalog Number : BLD1200

Device Description : Single-use Blade-Filter to be used with Microlyzer Cartridge

Device Class : 1

Duns Number: 505280884

Premarket Exempt : Yes

Product Code : OJT

Prescription Use : Yes

Device Count : 1

MICROLYZER - 08681092003159 Catalog Number : BLD600

Device Description : Single-use Blade-Filter to be used with Microlyzer Cartridge

Device Class : 1

Duns Number: 505280884

Premarket Exempt : Yes

Product Code : OJT

Prescription Use : Yes

Device Count : 1

MICROLYZER FAT PROCESSOR 2400 - 08682754370008 Catalog Number : MC 3101

Device Description : MICROLYZER FAT PROCESSOR 2400

Device Class : 1

Duns Number: 505280884

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

MICROLYZER FAT PROCESSOR 1200 - 08682754370015 Catalog Number : MC 3102

Device Description : MICROLYZER FAT PROCESSOR 1200

Device Class : 1

Duns Number: 505280884

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

MICROLYZER Fat Processor 600 - 08682754370022 Catalog Number : MC 3103

Device Description : MICROLYZER Fat Processor 600

Device Class : 1

Duns Number: 505280884

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

MICROLYZER Fat Processor 41 - 08682754370039 Catalog Number : MC3104

Device Description : MICROLYZER Fat Processor 41

Device Class : 1

Duns Number: 505280884

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

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