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

Yes No

Clear

Greatbatch Steerable Sheath - 00821329000416 Catalog Number : 10876-001

Device Description : Steerable Sheath, 8 French

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

Greatbatch Steerable Sheath - 00821329000423 Catalog Number : 10876-002

Device Description : Steerable Sheath, 9 French

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DQY

Prescription Use : Yes

Device Count : 1

RadialSeal™ Introducer Kit, SS Wire - 00821329000430 Catalog Number :

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

RadialSeal™ Introducer Kit, SS Wire - 00821329000447 Catalog Number :

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

RadialSeal™ Introducer Kit, SS Wire - 00821329000454 Catalog Number :

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

RadialSeal™ Introducer Kit, Poly Wire - 00821329000461 Catalog Number :

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

RadialSeal™ Introducer Kit, Poly Wire - 00821329000478 Catalog Number :

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

RadialSeal™ Introducer Kit, Poly Wire - 00821329000485 Catalog Number :

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PTFE Peelable Introducer Kit - 00821329000492 Catalog Number : 7129

Device Class :

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

PTFE Peelable Introducer Kit - 00821329000508 Catalog Number : 7131

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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