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 QWIX® - 10381780041672 Catalog Number :

Device Description : The propylux cylinder maintains the K-wires in the container with reference 1219 The propylux cylinder maintains the K-wires in the container with reference 121950ND used in the transport and the sterilization of the associated instruments and non sterile implants.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

KALIX® - 10381780041689 Catalog Number :

Device Description : The radel sterilization container is used in the transport and the sterilization The radel sterilization container is used in the transport and the sterilization of instruments, including one base with reference 119881ND and one lid with reference 119882ND.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

KALIX® - 10381780041696 Catalog Number :

Device Description : The base is part of the container with reference 119880ND used in the transport The base is part of the container with reference 119880ND used in the transport and the sterillization of the associated instruments. It is composed of one base and three silicone bumpers to securely maintain the devices.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

KALIX® - 10381780041702 Catalog Number :

Device Description : The lid is part of the container with reference 119880ND used in the transport a The lid is part of the container with reference 119880ND used in the transport and the sterillization of instruments.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

FOREFOOT SOLUTIONS™ - 10381780041719 Catalog Number :

Device Description : The radel lower tray is part of the container used in the transport and the ster The radel lower tray is part of the container used in the transport and the sterilization of the instruments and non sterile implants. It is composed of one tray and eleven silicone bumpers to securely maintain the devices.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

FOREFOOT SOLUTIONS™ - 10381780041726 Catalog Number :

Device Description : The radel upper tray is part of the container used in the transport and the ster The radel upper tray is part of the container used in the transport and the sterilization of the instruments and non sterile implants. It is composed of one tray and three silicone bumpers to securely maintain the devices.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

FOREFOOT SOLUTIONS™ - 10381780041733 Catalog Number :

Device Description : The radel implant insert is part of the container used in the transport and the The radel implant insert is part of the container used in the transport and the sterilization of the associated instruments and non sterile implants.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

Newdeal® - 10381780041740 Catalog Number :

Device Description : The four blue silicone wedges are part of the container bases used in the transp The four blue silicone wedges are part of the container bases used in the transport and the sterillization of the instruments and non-sterile implants.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

QWIX® - 10381780041757 Catalog Number :

Device Description : The container is used in the transport and the sterilization of the QWIX® 3.0mm The container is used in the transport and the sterilization of the QWIX® 3.0mm screw associated instruments, including one base with reference 119931ND 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® - 10381780041764 Catalog Number :

Device Description : The 3.0mm screw base is part of the container with reference 119930ND used in th The 3.0mm screw base is part of the container with reference 119930ND used in the transport and the sterillization of the QWIX® 3.0mm screw associated instruments. It is composed of one base with three silicone bumpers to securely maintain the devices, one carpet with reference 119933ND and one cylinder with reference 119934ND.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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