Greatbatch Ltd

Address:9305 SW Nimbus Ave,BEAVERTON,OR,97008,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

Introducer, Catheter (DYB) (8) Catheter, Percutaneous (DQY) (2)

Premarket Exempt

No Yes

Clear

PTFE Peelable Introducer Kit - 00821329000515 Catalog Number : 7133

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PTFE Peelable Introducer Kit - 00821329000522 Catalog Number : 7090

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PTFE Peelable Introducer Kit - 00821329000539 Catalog Number : 7096

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PTFE Peelable Introducer Kit - 00821329000546 Catalog Number : 7097

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PTFE Peelable Introducer Kit - 00821329000553 Catalog Number : 7099

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Boston Scientific Channel Steerable Sheath - 00821329000652 Catalog Number : M004CS100

Device Description : Channel Steerable Sheath, 8 French

Device Class :

Duns Number: 968623467

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Boston Scientific Channel Steerable Sheath - 00821329000669 Catalog Number : M004CS200

Device Description : Channel Steerable Sheath, 9 French

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

OptiSeal™ - 00821329000676 Catalog Number : 1000092-001

Device Description : Valved Peelable PTFE Introducer

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

OptiSeal™ - 00821329000683 Catalog Number : 1000092-002

Device Description : Valved Peelable PTFE Introducer

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

OptiSeal™ - 00821329000690 Catalog Number : 1000092-003

Device Description : Valved Peelable PTFE Introducer

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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