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

TRAY, SURGICAL, INSTRUMENT (FSM) (10)

Premarket Exempt

No Yes

Clear

LARGE UNI-CLIP® - 10381780041986 Catalog Number :

Device Description : The sterilisation container is used in the transport and the sterilization of th

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LARGE UNI-CLIP® - 10381780041993 Catalog Number :

Device Description : The radel lid is part of the container with reference 119990ND used in the trans

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LARGE UNI-CLIP® - 10381780042006 Catalog Number :

Device Description : The silicone base is part of the container with reference 119990ND used in the t

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LARGE UNI-CLIP® - 10381780042013 Catalog Number :

Device Description : The propylux cylinder maintains the K-wires in the container with reference 1199

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LARGE QWIX® - 10381780042037 Catalog Number :

Device Description : The instrumentation set is used in the transport and the sterilization of the LA

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LARGE QWIX® - 10381780042044 Catalog Number :

Device Description : The container is used in the transport and the sterilization of the LARGE QWIX®

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LARGE QWIX® - 10381780042051 Catalog Number :

Device Description : The stainless steel base is part of the container with reference 121950ND used i

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LARGE QWIX® - 10381780042068 Catalog Number :

Device Description : The washer rack lid is part of the screw rack with reference 119955ND used in th

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LARGE QWIX® - 10381780042075 Catalog Number :

Device Description : The implant tray base is part of the set with reference 121960ND used in the tra

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

LARGE QWIX® - 10381780042082 Catalog Number :

Device Description : The washer rack lid is part of the screw rack with reference 121975ND used in t

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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