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)

Premarket Exempt

Clear

Protégé™ GPS™ - 00821684071694 Catalog Number :

Device Description : STENT SERB65-14-20-120 PROTEGE GPS V05

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00821684071700 Catalog Number :

Device Description : STENT SERB65-14-20-80 PROTEGE GPS V05

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00821684071717 Catalog Number :

Device Description : STENT SERB65-14-30-120 PROTEGE GPS V05

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00821684071724 Catalog Number :

Device Description : STENT SERB65-14-30-80 PROTEGE GPS V05

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00821684071731 Catalog Number :

Device Description : STENT SERB65-14-40-120 PROTEGE GPS V05

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00821684071748 Catalog Number :

Device Description : STENT SERB65-14-40-80 PROTEGE GPS V05

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00821684071755 Catalog Number :

Device Description : STENT SERB65-14-60-120 PROTEGE GPS V05

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00821684071762 Catalog Number :

Device Description : STENT SERB65-14-60-80 PROTEGE GPS V05

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00821684071779 Catalog Number :

Device Description : STENT SERB65-14-80-120 PROTEGE GPS V05

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

Protégé™ GPS™ - 00821684071786 Catalog Number :

Device Description : STENT SERB65-14-80-80 PROTEGE GPS V05

Device Class : 2

Duns Number: 117446916

Premarket Exempt : No

Product Code : FGE

Prescription Use : Yes

Device Count : 1

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