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

No Yes

Clear

Hallu®-FIX - 10381780042099 Catalog Number :

Device Description : The stainless steel and radel container is used in the transport and the sterili The stainless steel and radel container is used in the transport and the sterilization of the associated instruments and non sterile implants. It includes one base with reference 129931ND, one HALLU®-C plate rack with reference 129932ND, one HALLU®-S plate rack with reference 129933ND, one HALLU-FIX® screw rack with reference 129936ND 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

Hallu®-FIX - 10381780042105 Catalog Number :

Device Description : The stainless steel base is part of the container with reference 129930ND used i The stainless steel base is part of the container with reference 129930ND used in the transport and the sterilization of the associated instruments and non sterile implants. It is composed of one base and four 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

Hallu®-FIX - 10381780042112 Catalog Number :

Device Description : The radel plate tray is part of the container with reference 129930ND used in t The radel plate tray is part of the container with reference 129930ND used in the transport and the sterilization of the HALLU®-C associated instruments and non sterile implants. It has one silicone bumper to securely maintain the HALLU®-C plates.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

Hallu®-FIX - 10381780042129 Catalog Number :

Device Description : The radel plate tray is part of the container with reference 129930ND used in th The radel plate tray is part of the container with reference 129930ND used in the transport and the sterilization of the HALLU®-S associated instruments and non sterile implants. It has one silicone bumper to securely maintain the HALLU®-S plates.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

Hallu®-FIX - 10381780042136 Catalog Number :

Device Description : The radel container is used in the transport and the sterilization of the HALLU® The radel container is used in the transport and the sterilization of the HALLU® REAM associated instruments. It includes one base with reference 129938ND and one lid with reference 996100ND.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

Hallu®-FIX - 10381780042143 Catalog Number :

Device Description : The radel screw rack is part of the container with reference 129930ND used in th The radel screw rack is part of the container with reference 129930ND used in the transport and the sterilization of the HALLU® FIX 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

CALCANEA™ - 10381780042150 Catalog Number :

Device Description : The radel container is used in the transport and the sterilization of the associ The radel container is used in the transport and the sterilization of the associated instruments and non sterile implants. It includes one base with reference 129953ND, one plate tray with reference 129951ND, one insert with reference 129952ND and one lid with reference 129959ND.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

CALCANEA™ - 10381780042167 Catalog Number :

Device Description : The radel implants tray is part of the container with reference 129950ND used in The radel implants tray is part of the container with reference 129950ND used in the transport and the sterilization of the associated instruments.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

CALCANEA™ - 10381780042174 Catalog Number :

Device Description : The insert is part of the container with reference 129950ND used in the transpor The insert is part of the container with reference 129950ND used in the transport and the sterilization of the associated instruments.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

CALCANEA™ - 10381780042181 Catalog Number :

Device Description : The base is part of the container with reference 129950ND used in the transport The base is part of the container with reference 129950ND 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

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