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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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OptiSeal™ - 00821329001116

Valved Peelable PTFE Introducer
Greatbatch Ltd
1003975-012
In Commercial Distribution

  • 20821329001110 ()
  • 00821329001116 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator OD: 3.6 mm
  • Sheath ID: 3.4 mm
  • Sheath Effective Length: 25 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 10 French
1003975-012

  • Vascular catheter introduction set, nonimplantable

OptiSeal™ - 00821329001109

Valved Peelable PTFE Introducer
Greatbatch Ltd
1003975-011
In Commercial Distribution

  • 20821329001103 ()
  • 00821329001109 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator OD: 3.2 mm
  • Sheath ID: 3.1 mm
  • Sheath Effective Length: 25 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 9 French
1003975-011

  • Vascular catheter introduction set, nonimplantable

OptiSeal™ - 00821329001093

Valved Peelable PTFE Introducer
Greatbatch Ltd
1003975-010
In Commercial Distribution

  • 20821329001097 ()
  • 00821329001093 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Sheath OD: 2.9 mm
  • Sheath ID: 2.7 mm
  • Sheath Effective Length: 25 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 8 French
1003975-010

  • Vascular catheter introduction set, nonimplantable

OptiSeal™ - 00821329001086

Valved Peelable PTFE Introducer
Greatbatch Ltd
1003975-009
In Commercial Distribution

  • 20821329001080 ()
  • 00821329001086 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator OD: 2.6 mm
  • Sheath ID: 2.4 mm
  • Sheath Effective Length: 25 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 7 French
1003975-009

  • Vascular catheter introduction set, nonimplantable

OptiSeal™ - 00821329001079

Valved Peelable PTFE Introducer
Greatbatch Ltd
1003975-008
In Commercial Distribution

  • 20821329001073 ()
  • 00821329001079 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator OD: 2.3 mm
  • Sheath ID: 2.1 mm
  • Sheath Effective Length: 25 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 6 French
1003975-008

  • Vascular catheter introduction set, nonimplantable

OptiSeal™ - 00821329001062

Valved Peelable PTFE Introducer
Greatbatch Ltd
1003975-007
In Commercial Distribution

  • 00821329001062 ()
  • 20821329001066 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator OD: 4.2 mm
  • Sheath ID: 4.1 mm
  • Sheath Effective Length: 13 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 12 French
1003975-007

  • Vascular catheter introduction set, nonimplantable

OptiSeal™ - 00821329001055

Valved Peelable PTFE Introducer
Greatbatch Ltd
1003975-006
In Commercial Distribution

  • 20821329001059 ()
  • 00821329001055 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator OD: 3.9 mm
  • Sheath ID: 3.7 mm
  • Sheath Effective Length: 13 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 11 French
1003975-006

  • Vascular catheter introduction set, nonimplantable

OptiSeal™ - 00821329001048

Valved Peelable PTFE Introducer
Greatbatch Ltd
1003975-005
In Commercial Distribution

  • 20821329001042 ()
  • 00821329001048 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator OD: 3.6 mm
  • Sheath ID: 3.4 mm
  • Sheath Effective Length: 13 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 10 French
1003975-005

  • Vascular catheter introduction set, nonimplantable

OptiSeal™ - 00821329001031

Valved Peelable PTFE Introducer
Greatbatch Ltd
1003975-004
In Commercial Distribution

  • 20821329001035 ()
  • 00821329001031 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator OD: 3.2 mm
  • Sheath ID: 3.1 mm
  • Sheath Effective Length: 13 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 9 French
1003975-004

  • Vascular catheter introduction set, nonimplantable

OptiSeal™ - 00821329001024

Valved Peelable PTFE Introducer
Greatbatch Ltd
1003975-003
In Commercial Distribution

  • 20821329001028 ()
  • 00821329001024 ()

  • Syringe Total Volume: 12 milliliter
  • Needle OD/ Gauge: 1.4 mm (18 Ga); Needle ID: 0.9 mm; Needle Length: 70 mm
  • Guidewire OD: 0.89 mm
  • Guidewire Length: 60 cm
  • Dilator OD: 2.9 mm
  • Sheath ID: 2.7 mm
  • Sheath Effective Length: 13 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 8 French
1003975-003

  • Vascular catheter introduction set, nonimplantable
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