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) (4) Needle, Biopsy, Cardiovascular (DWO) (4) Instrument, Biopsy (KNW) (3) Device, Percutaneous, Biopsy (MJG) (2)

Premarket Exempt

Yes No

Clear

PenBone - 08058341214428 Catalog Number : PIP1830/70

Device Description : 10 CS - BONE MARROW ASPIRATIONNEEDLE, BLUE LINE, MEDIUM18G X 30/70mm

Device Class : 1

Duns Number: 447228586

Premarket Exempt : Yes

Product Code : DWO

Prescription Use : Yes

Device Count : 1

PenBoneB - 08058341214435 Catalog Number : PIP1810/50

Device Description : DISPOSABLE NEEDLE FORBONE MARROW ASPIRATION18Gx10/50mm

Device Class : 1

Duns Number: 447228586

Premarket Exempt : Yes

Product Code : DWO

Prescription Use : Yes

Device Count : 1

PenBone - 08058341214442 Catalog Number : PIP1430/70

Device Description : 10 CS - BONE MARROW ASPIRATIONNEEDLE, BLUE LINE , MEDIUM14G X 30/70mm

Device Class : 1

Duns Number: 447228586

Premarket Exempt : Yes

Product Code : DWO

Prescription Use : Yes

Device Count : 1

Themy - 08058341215159 Catalog Number : TYC2020

Device Description : THEMY AUTOMATIC NEEDLE 20Gx200mmNOTCH 20mm, WITH COAXIAL NEEDLEFOR SOFT TISSUE BIOPSY

Device Class : 2

Duns Number: 447228586

Premarket Exempt : No

Product Code : FCG

Prescription Use : Yes

Device Count : 1

FastCutP - 08058341215166 Catalog Number : MGP1612

Device Description : CS 10-DISPOSABLE NEEDLE 16Gx120mmFOR SOFT TISSUE BIOPSYCOMPATIBLE AUTOMATIC PROMAG® GUN

Device Class : 1

Duns Number: 447228586

Premarket Exempt : Yes

Product Code : MJG

Prescription Use : Yes

Device Count : 1

PALIUM COAXIAL - 08058341215203 Catalog Number : MGC1210

Device Description : GUILLOTINE NEEDLE 12Gx 100 mmFOR SOFT TISSUE FOR PALIUM AND MAGNUM BARD TMWITH C GUILLOTINE NEEDLE 12Gx 100 mmFOR SOFT TISSUE FOR PALIUM AND MAGNUM BARD TMWITH COXIAL 11G X 74MM

Device Class : 1

Duns Number: 447228586

Premarket Exempt : Yes

Product Code : MJG

Prescription Use : Yes

Device Count : 1

PenBone - 08058341215500 Catalog Number : PIP1410/50

Device Description : BONE MARROW ASPIRATIONNEEDLE, BLUE LINE , SHORT14G X 10/50mm

Device Class : 1

Duns Number: 447228586

Premarket Exempt : Yes

Product Code : DWO

Prescription Use : Yes

Device Count : 1

Themy - 08058341217054 Catalog Number : TY1211

Device Description : DISPOSABLE AUTOMATIC DEVICE 12G X 110 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

Themy - 08058341217061 Catalog Number : TY1209

Device Description : DISPOSABLE AUTOMATIC DEVICE 12G X 90 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

SemiCut Coax. - 08058341217313 Catalog Number : PD0PP1407

Device Description : DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 14G X 70 mm FOR SOFT TISSUE BIOPSY WI DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 14G 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

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