M.D.L. S.R.L.

Address:Via Tavani 1/a,Delebio (So) Sondrio,IT

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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

Biopsy Needle (FCG) (2) Device, Percutaneous, Biopsy (MJG) (2) Instrument, Biopsy (KNW) (2)

Premarket Exempt

Yes No

Clear

SemiCut Coax. - 08058341217344 Catalog Number : PD0PP1807

Device Description : DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 18G X 70 mm FOR SOFT TISSUE BIOPSY WI DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 18G X 70 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE LUER, WITH INTRODUCER

Device Class : 2

Duns Number: 447228586

Premarket Exempt : No

Product Code : FCG, KNW

Prescription Use : Yes

Device Count : 1

Themy - 08058341217634 Catalog Number : TY1206

Device Description : DISPOSABLE AUTOMATIC DEVICE 12G X 60 mm FOR SOFT TISSUE BIOPSY, NOTCH OF 20 mm

Device Class : 2

Duns Number: 447228586

Premarket Exempt : No

Product Code : FCG, KNW

Prescription Use : Yes

Device Count : 1

HandCut - 08058341219188 Catalog Number : PM18114

Device Description : 10 CS-DISPOSABLE NEEDLE 18G x114mmFOR SOFT TISSUE BIOPSYWITH MANUAL ACTION

Device Class : 1

Duns Number: 447228586

Premarket Exempt : Yes

Product Code : MJG

Prescription Use : Yes

Device Count : 1

Intro - 08058341219225 Catalog Number : PT19075

Device Description : 10 CS - COAXIAL INTRODUCER NEEDLE17G X 140mm

Device Class : 1

Duns Number: 447228586

Premarket Exempt : Yes

Product Code : MJG

Prescription Use : Yes

Device Count : 1

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