NEWDEAL

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

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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

Yes No

Clear

ADVANSYS® - 10381780042297 Catalog Number :

Device Description : The radel cylinder maintains the K-wires and the drills in the containers used The radel cylinder maintains the K-wires and the drills in the containers used in the transport and the sterilization of the ADVANSYS® associated instruments.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ADVANSYS® - 10381780042303 Catalog Number :

Device Description : The hindfoot instrument base is part of the container with reference 169101ND us The hindfoot instrument base is part of the container with reference 169101ND used in the transport and the sterilization of the associated instruments. It is composed of one base and seven 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

ADVANSYS® - 10381780042310 Catalog Number :

Device Description : The radel medio plate base is part of the container with reference 169102ND used The radel medio plate base is part of the container with reference 169102ND used in the transport and the sterilization of the associated instruments. 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

ADVANSYS® - 10381780042327 Catalog Number :

Device Description : The stainless steel TTC plate container is used in the transport and the sterili The stainless steel TTC plate container is used in the transport and the sterilization of the associated non sterile implants. It includes one base with reference 188211ND, one screw rack with reference 188215ND 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

ADVANSYS® - 10381780042334 Catalog Number :

Device Description : The midfoot implant container is used in the transport and the sterilization of The midfoot implant container is used in the transport and the sterilization of the non sterile implants and their associated instruments. It includes one base with reference 188212ND, one screw rack with reference 188216ND, one lid with reference 996200ND and one carpet with reference 188219ND.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

ADVANSYS® - 10381780042341 Catalog Number :

Device Description : The stainless steel base is part of the container with reference 188201ND used i The stainless steel base is part of the container with reference 188201ND used in the transport and the sterilization of the associated non sterile implants. It is composed of one base and two 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

ADVANSYS® - 10381780042358 Catalog Number :

Device Description : The basis is part of the container which product number is 188202ND and that is The basis is part of the container which product number is 188202ND and that is used for transport and sterilization of instruments and non sterile implants.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ADVANSYS® - 10381780042365 Catalog Number :

Device Description : The screw rack is part of the container which product number is 188201ND and tha The screw rack is part of the container which product number is 188201ND and that is used for transport and sterilization of non sterile implants.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

ADVANSYS® - 10381780042372 Catalog Number :

Device Description : The screw rack is part of the container which product number is 188202ND and tha The screw rack is part of the container which product number is 188202ND and that is used for transport and sterilization of instruments and non sterile implants.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

B-BOP® - 10381780042389 Catalog Number :

Device Description : The sterilization container is used for transport and sterilization of instruments.

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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