EV3, INC

EV3, INC

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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

CATHETER, BILIARY, DIAGNOSTIC (FGE) (10) STENT, ILIAC (NIO) (10)

Premarket Exempt

No

Clear

Protégé™ GPS™ - 00643169728905 Catalog Number :

Device Description : STENT SERB65-09-20-120 PROTEGE GPS V06

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : NIO, FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00643169728912 Catalog Number :

Device Description : STENT SERB65-09-20-80 PROTEGE GPS V06

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE, NIO

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00643169728929 Catalog Number :

Device Description : STENT SERB65-09-30-120 PROTEGE GPS V06

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : NIO, FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00643169728936 Catalog Number :

Device Description : STENT SERB65-09-30-80 PROTEGE GPS V06

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : NIO, FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00643169728943 Catalog Number :

Device Description : STENT SERB65-09-40-120 PROTEGE GPS V06

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE, NIO

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00643169728950 Catalog Number :

Device Description : STENT SERB65-09-40-80 PROTEGE GPS V06

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : NIO, FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00643169728967 Catalog Number :

Device Description : STENT SERB65-09-60-120 PROTEGE GPS V06

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE, NIO

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00643169728974 Catalog Number :

Device Description : STENT SERB65-09-60-80 PROTEGE GPS V06

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : NIO, FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00643169728981 Catalog Number :

Device Description : STENT SERB65-09-80-120 PROTEGE GPS V06

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : NIO, FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00643169728998 Catalog Number :

Device Description : STENT SERB65-09-80-80 PROTEGE GPS V06

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : NIO, FGE

Prescription Use : Yes

Device Count : 1

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