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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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Valved Peelable PTFE Introducer
Greatbatch Ltd
1000093-020
In Commercial Distribution

  • 20821329000908 ()
  • 00821329000904 ()

  • 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
7445

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000093-019
In Commercial Distribution

  • 20821329000892 ()
  • 00821329000898 ()

  • 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
7444

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000093-018
In Commercial Distribution

  • 20821329000885 ()
  • 00821329000881 ()

  • 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
7443

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000093-017
In Commercial Distribution

  • 20821329000878 ()
  • 00821329000874 ()

  • 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: 13 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 8 French
7442

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000093-016
In Commercial Distribution

  • 20821329000861 ()
  • 00821329000867 ()

  • 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: 13 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 7 French
7441

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000093-015
In Commercial Distribution

  • 20821329000854 ()
  • 00821329000850 ()

  • 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: 13 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 6 French
7440

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000093-014
In Commercial Distribution

  • 20821329000847 ()
  • 00821329000843 ()

  • 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: 25 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 12 French
1000093-014

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000093-013
In Commercial Distribution

  • 20821329000830 ()
  • 00821329000836 ()

  • 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: 25 cm
  • Dilator ID: 0.9 mm
  • Catheter Gauge: 11 French
1000093-013

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000093-012
In Commercial Distribution

  • 20821329000823 ()
  • 00821329000829 ()

  • 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
1000093-012

  • Vascular catheter introduction set, nonimplantable
Valved Peelable PTFE Introducer
Greatbatch Ltd
1000093-011
In Commercial Distribution

  • 20821329000816 ()
  • 00821329000812 ()

  • 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
1000093-011

  • Vascular catheter introduction set, nonimplantable
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