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

Hallu®-FIX - 10381780042099 Catalog Number :

Device Description : The stainless steel and radel container is used in the transport and the sterili

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

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

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

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®

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

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

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

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

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

Device Class : 1

Duns Number: 536935331

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

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