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™ - 00821329001000 Catalog Number : 1003975-001

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™ - 00821329001017 Catalog Number : 1003975-002

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™ - 00821329001024 Catalog Number : 1003975-003

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™ - 00821329001031 Catalog Number : 1003975-004

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™ - 00821329001048 Catalog Number : 1003975-005

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™ - 00821329001055 Catalog Number : 1003975-006

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™ - 00821329001062 Catalog Number : 1003975-007

Device Description : Valved Peelable PTFE Introducer

Device Class :

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

OptiSeal™ - 00821329001079 Catalog Number : 1003975-008

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™ - 00821329001086 Catalog Number : 1003975-009

Device Description : Valved Peelable PTFE Introducer

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

OptiSeal™ - 00821329001093 Catalog Number : 1003975-010

Device Description : Valved Peelable PTFE Introducer

Device Class : 2

Duns Number: 968623467

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

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