GENZYME CORPORATION

Address:1125 PLEASANTVIEW TERRACE,Ridgefield,NJ,07657,US

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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

Reagents, Specific, Analyte (MVU) (7) BARRIER, ABSORABLE, ADHESION (MCN) (2) Acid, hyaluronic, intraarticular (MOZ) (1)

Premarket Exempt

No Yes

Clear

ALDURAZYME 2.9 MG/5ML MEDSU VL1 DIAG US - 00358468000019 Catalog Number :

Device Description : ALDURAZYME 2.9 MG/5ML MEDSU VL1 DIAG US

Device Class : 1

Duns Number: 050424395

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

MYOZYME 50MG/10ML MEDSU VL1 DIAG US - 00358468000026 Catalog Number :

Device Description : MYOZYME 50MG/10ML MEDSU VL1 DIAG US

Device Class : 1

Duns Number: 050424395

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : No

Device Count : 1

FABRAZYME 35MG/7ML VL1 DIAG US - 00358468000033 Catalog Number :

Device Description : FABRAZYME 35MG/7ML VL1 DIAG US

Device Class : 1

Duns Number: 050424395

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

CEREZYME 400IU MEDSU VL1 DIAG US - 00358468000040 Catalog Number :

Device Description : CEREZYME 400IU MEDSU VL1 DIAG US

Device Class : 1

Duns Number: 050424395

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

NEOGAA AVALGLUCO 100MG/20ML MEDSU VL1 US - 00358468000057 Catalog Number :

Device Description : NEOGAA AVALGLUCO 100MG/20ML MEDSU VL1 US

Device Class : 1

Duns Number: 050424395

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US - 00358468000064 Catalog Number :

Device Description : OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US

Device Class : 1

Duns Number: 050424395

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US - 00358468000071 Catalog Number :

Device Description : GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US

Device Class : 1

Duns Number: 050424395

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

Synvisc® - 00358468019103 Catalog Number :

Device Description : Acid, Hyaluronic, Intraarticular

Device Class :

Duns Number: 098066215

Premarket Exempt : No

Product Code : MOZ

Prescription Use : Yes

Device Count : 3

Seprafilm® - 00358468430120 Catalog Number :

Device Description : Barrier, Absorbable, Adhesion

Device Class :

Duns Number: 943130096

Premarket Exempt : No

Product Code : MCN

Prescription Use : Yes

Device Count : 10

Seprafilm® Procedure Pack - 00358468508621 Catalog Number :

Device Description : Barrier, Absorbable, Adhesion

Device Class :

Duns Number: 943130096

Premarket Exempt : No

Product Code : MCN

Prescription Use : Yes

Device Count : 5

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