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

I.CO.S® - 10381780041887 Catalog Number :

Device Description : The radel insert is part of the container with reference 119976ND used in the tr The radel insert is part of the container with reference 119976ND used in the transport and the sterillization of the I.CO.S® 6.5mm non-sterile implants. It is composed of one thermoformed tray with holes for the 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

I.CO.S® - 10381780041894 Catalog Number :

Device Description : The base is part of the removal set with reference 119975ND. It is used in the t The base is part of the removal set with reference 119975ND. It is used in the transport and the sterilization of the associated instruments. It is composed of one base and five 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

I.CO.S® - 10381780041900 Catalog Number :

Device Description : The silicone base is part of the container with reference 119974ND used in the t The silicone base is part of the container with reference 119974ND used in the transport and the sterillization of the I.CO.S® 4mm compression screw associated instruments and non-sterile implants . It is composed of one base and six 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

I.CO.S® - 10381780041917 Catalog Number :

Device Description : The radel lid is part of the container used in the transport and the sterilliza The radel lid is part of the container used in the transport and the sterillization of the I.CO.S® 6.5mm compression screw associated instruments and non-sterile implants.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

I.CO.S® - 10381780041924 Catalog Number :

Device Description : The base is part of the container with reference 119976ND used in the transport The base is part of the container with reference 119976ND used in the transport and the sterillization of the I.CO.S® 6.5mm compression screw associated instruments and non-sterile implants. It is composed of one base and six 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

I.CO.S® - 10381780041931 Catalog Number :

Device Description : The lid is part of the removal set with reference 119975ND used in the transport The lid is part of the removal set with reference 119975ND used in the transport and the sterilization of the associated instruments.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

I.CO.S® - 10381780041948 Catalog Number :

Device Description : The complete box is used in the transport and the sterillization of the I.CO.S® The complete box is used in the transport and the sterillization of the I.CO.S® 4mm compression screw associated instruments and non-sterile implants. It includes one base with reference 119956ND, one radel insert with reference 119951ND, one insert lid with reference 119949ND and one lid with reference 996200ND.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

I.CO.S® - 10381780041955 Catalog Number :

Device Description : The complete box is used in the transport and the sterillization of the I.CO.S® The complete box is used in the transport and the sterillization of the I.CO.S® 6.5mm compression screw associated instruments and non-sterile implants. It includes one base with reference 119958ND, one radel insert with reference 119953ND, one insert lid with reference 119949ND, four wedges with reference 119909ND and one lid with reference 996200ND.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

I.CO.S® - 10381780041962 Catalog Number :

Device Description : The propylux cylinder maintains the K-wires in the removal set with reference 11 The propylux cylinder maintains the K-wires in the removal set with reference 119975ND used in the transport and the sterilization of the I.CO.S® associated removal instrumentation.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

I.CO.S® - 10381780041979 Catalog Number :

Device Description : The radel insert is part of the container with reference 119985ND used in the tr The radel insert is part of the container with reference 119985ND used in the transport and the sterilization of the I.CO.S® XL compression screw associated instruments and non-sterile implants. It has 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

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