INSTITUT GEORGES LOPEZ

Address:6 ROUTE DE SAINT BONNET,ST LAURENT DE CHAMOUSSET 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

Set, Perfusion, Kidney, Disposable (KDL) (3) System, Perfusion, Kidney (KDN) (2) System And Accessories, Isolated Heart, Transport And Preservation (MSB) (1)

Premarket Exempt

Clear

BEL-GEN Cold Storage Solution - 13700911900119 Catalog Number :

Device Description : Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of k Clear, sterile, non-pyrogenic solution for hypothermic flushing and storage of kidney, liver and pancreas.

Device Class :

Duns Number: 393146183

Premarket Exempt : No

Product Code : KDN, KDL

Prescription Use : Yes

Device Count : 1

CELSIOR Cold Storage Solution - 13700911900126 Catalog Number : 533682

Device Description : Sterile, non-pyrogenic cold flush, storage and transport solution for Hearts.

Device Class :

Duns Number: 393146183

Premarket Exempt : No

Product Code : MSB

Prescription Use : Yes

Device Count : 1

PERF-GEN Pulsatile Perfusion Solution - 13700911900492 Catalog Number :

Device Description : Clear, sterile, non-pyrogenic solution intended to be used for flushing and cont Clear, sterile, non-pyrogenic solution intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.

Device Class : 2

Duns Number: 393146183

Premarket Exempt : No

Product Code : KDL

Prescription Use : Yes

Device Count : 1

BEL-GEN Cold Storage Solution - 13700911900522 Catalog Number :

Device Class : 2

Duns Number: 393146183

Premarket Exempt : No

Product Code : KDN, KDL

Prescription Use : Yes

Device Count : 1

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