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) (10)

Premarket Exempt

No Yes

Clear

OptiSeal™ - 00821329000706 Catalog Number : 1000092-004

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™ - 00821329000713 Catalog Number : 1000093-001

Device Description : Valved Peelable PTFE Introducer

Device Class :

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

OptiSeal™ - 00821329000720 Catalog Number : 1000093-002

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™ - 00821329000737 Catalog Number : 1000093-003

Device Description : Valved Peelable PTFE Introducer

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

OptiSeal™ - 00821329000744 Catalog Number : 1000093-004

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™ - 00821329000751 Catalog Number : 1000093-005

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™ - 00821329000768 Catalog Number : 1000093-006

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™ - 00821329000775 Catalog Number : 1000093-007

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™ - 00821329000782 Catalog Number : 1000093-008

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™ - 00821329000799 Catalog Number : 1000093-009

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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