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

QWIX® - 10381780041771 Catalog Number :

Device Description : The silicone lid is part of the bases with references 119931ND and 119936ND used The silicone lid is part of the bases with references 119931ND and 119936ND used in the transport and the sterillization of the QWIX® 3.0-4.3mm screw associated instruments.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

QWIX® - 10381780041788 Catalog Number :

Device Description : The silicone carpet is part of the base with reference 119931ND used in the tran The silicone carpet is part of the base with reference 119931ND used in the transport and the sterillization of the QWIX® 3.0mm screw associated instruments.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

QWIX® - 10381780041795 Catalog Number :

Device Description : The cylinder maintains the K-wires in the base with reference 119931ND used in t The cylinder maintains the K-wires in the base with reference 119931ND used in the transport and the sterillization of the QWIX® 3.0mm screw associated instruments.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

QWIX® - 10381780041801 Catalog Number :

Device Description : The stainless steel container is used in the transport and the sterilization of The stainless steel container is used in the transport and the sterilization of the QWIX® 4.3mm screw associated instruments. It includes one base with reference 119936ND and one lid with reference 996400ND.The transport and sterilization containers are not intended to maintain sterility.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

QWIX® - 10381780041818 Catalog Number :

Device Description : The radel screw base is part of the container with reference 119935ND used in th The radel screw base is part of the container with reference 119935ND used in the transport and the sterilization of the QWIX® 4.3mm screw associated instruments. It is composed of one rack with three silicone bumpers to securely maintain the devices, one cylinder with reference 119937ND and one carpet with reference 119938ND.The transport and sterilization containers are not intended to maintain sterility.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

QWIX® - 10381780041825 Catalog Number :

Device Description : The propylux cylinder maintains the K-wires in the base with reference 119936ND The propylux cylinder maintains the K-wires in the base with reference 119936ND used in the transport and the sterilization of the QWIX® 4.3mm screw associated instruments.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

QWIX® - 10381780041832 Catalog Number :

Device Description : The silicone carpet is part of the base with reference 119936ND used in the tran The silicone carpet is part of the base with reference 119936ND used in the transport and the sterilization of the QWIX® 4.3mm screw associated instruments.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

QWIX® - 10381780041849 Catalog Number :

Device Description : The screw combined base is used in the transport and the sterilization of the QW The screw combined base is used in the transport and the sterilization of the QWIX® associated instruments. It is composed of one base with six silicone bumpers to securely maintain the devices, one lower screw rack and one upper screw rack and one silicone carpet with reference 119943ND.The transport and sterilization containers are not intended to maintain sterility.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

QWIX® - 10381780041863 Catalog Number :

Device Description : The silicone carpet is part of the combined base with reference 119941ND used in The silicone carpet is part of the combined base with reference 119941ND used in the transport and the sterilization of the QWIX® associated instruments.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

I.CO.S® - 10381780041870 Catalog Number :

Device Description : The radel insert is part of the container with reference 119974ND used in the tr The radel insert is part of the container with reference 119974ND used in the transport and the sterillization of the I.CO.S® 4mm non-sterile implants and their associated instruments. It is composed of one thermoformed plate with holes for screws.The transport and sterilization containers are not intended to maintain sterility.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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