Greatbatch Ltd

Address:2300 Berkshire Lane North,Minneapolis,MN,55441,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

Yes No

Clear

OptiSeal™ - 00821329000805 Catalog Number : 1000093-010

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™ - 00821329000812 Catalog Number : 1000093-011

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™ - 00821329000829 Catalog Number : 1000093-012

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™ - 00821329000836 Catalog Number : 1000093-013

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™ - 00821329000843 Catalog Number : 1000093-014

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™ - 00821329000850 Catalog Number : 7440

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™ - 00821329000867 Catalog Number : 7441

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™ - 00821329000874 Catalog Number : 7442

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™ - 00821329000881 Catalog Number : 7443

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™ - 00821329000898 Catalog Number : 7444

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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