NEWDEAL

Address:Immeuble S�quoia 2, 97 all�e Alexandre Borodine,Saint Priest Rhone,FR

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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

FORCEPS (HTD) (6) GAUGE, DEPTH (HTJ) (4)

Premarket Exempt

No Yes

Clear

N/A - 10381780044697 Catalog Number : 119651ND

Device Description : GENERAL INSTRUMENT Large Integra distraction Forceps 21cm Closed Arms

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTD

Prescription Use : Yes

Device Count : 1

N/A - 10381780044703 Catalog Number : 119653ND

Device Description : GENERAL INSTRUMENT Small Integra distraction Forceps 15cm Outspread Arms

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTD

Prescription Use : Yes

Device Count : 1

N/A - 10381780044710 Catalog Number : 119654ND

Device Description : GENERAL INSTRUMENT Small Integra distraction Forceps 15cm Closed Arms

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTD

Prescription Use : Yes

Device Count : 1

N/A - 10381780044727 Catalog Number : 119664ND

Device Description : GENERAL INSTRUMENT Large Integra distraction Forceps 21cm Outspread Arms

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTD

Prescription Use : Yes

Device Count : 1

UNI-CP™ - 10381780044734 Catalog Number :

Device Description : The compression forceps is used to open the olive of the plate to obtain compression.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTD

Prescription Use : Yes

Device Count : 1

SURFIX® - 10381780044741 Catalog Number :

Device Description : The GENERAL INSTRUMENT compression forceps is used to create a bone compression.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTD

Prescription Use : Yes

Device Count : 1

LARGE QWIX® - 10381780044765 Catalog Number :

Device Description : The measurer is used to measure the 200/250mm K-wire in place and decide the scr The measurer is used to measure the 200/250mm K-wire in place and decide the screw length to implant. It is placed so that the thin side is aligned with the base of the K-wire.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

FOREFOOT SOLUTIONS™ - 10381780044772 Catalog Number :

Device Description : The depth gauge is used to choose the length of the staple legs.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

I.CO.S® - 10381780044789 Catalog Number :

Device Description : The measurer is used to measure the 150/200mm K-wire in place and decide the com The measurer is used to measure the 150/200mm K-wire in place and decide the compression screw length to implant. It is placed so that the thin side is aligned with the base of the K-wire.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

I.CO.S® - 10381780044796 Catalog Number :

Device Description : The measurer is used to measure the 250mm K-wire in place and decide the compres The measurer is used to measure the 250mm K-wire in place and decide the compression screw length to implant. It is placed so that the thin side is aligned with the base of the K-wire.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : HTJ

Prescription Use : Yes

Device Count : 1

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