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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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Capella™ - 00821329400339

5 French Coaxial Micro-Introducer Kit
Greatbatch Ltd
1012868-005
In Commercial Distribution

  • 00821329400339 ()
  • 10821329400336 ()

  • .018" [.47 mm] SS/AuW Straight Tip Guidewire 45.0 cm
  • Needle, .55 mm ID, 0.9 mm OD, Echo Tip, 21 Ga. x 69.9 mm
  • Dilator 0.4 mm ID, 1.1 mm OD, 11.8 cm Length
  • 5 F Sheath 0.9 mm ID, 9.3 cm Length
  • Length: 9.3 Centimeter
MK5182

  • Vascular catheter introduction set, nonimplantable

Capella™ - 00821329400322

5 French Coaxial Micro-Introducer Kit
Greatbatch Ltd
1012868‐004
In Commercial Distribution

  • 10821329400329 ()
  • 00821329400322 ()

  • .018" [.47 mm] SS/SS Straight Tip Guidewire 45.0 cm
  • Needle, .55 mm ID, 0.9 mm OD, Echo Tip, 21 Ga. x 69.9 mm
  • Dilator 0.4 mm ID, 1.1 mm OD, 11.8 cm Length
  • 5 F Sheath 0.9 mm ID, 9.3 cm Length
  • Length: 9.3 Centimeter
MK5181

  • Vascular catheter introduction set, nonimplantable

Enteral Feeding - 00020451100180

Enteral Syringe 5 mL, ENFit
Medela LLC
ENF05
In Commercial Distribution

  • 20020451100184 ()
  • 00020451100180 ()


  • ENFit oral/enteral syringe, single-use

PHYSICA CR - 08033390087551

CR Femoral Component Left #5
LIMACORPORATE SPA
Left Femoral Comp.
In Commercial Distribution

  • 08033390087551 ()

  • #5-L
6513.09.550

  • Uncoated knee femur prosthesis, metallic

PHYSICA PS - 08033390095631

PS Femoral Component Left #5
LIMACORPORATE SPA
Left Femoral Comp.
In Commercial Distribution

  • 08033390095631 ()

  • #5-L
6515.09.550

  • Uncoated knee femur prosthesis, metallic

PHYSICA PS - 08033390095532

PS Femoral components Right #5
LIMACORPORATE SPA
Right Femoral Comp.
In Commercial Distribution

  • 08033390095532 ()

  • #5-R
6515.09.150

  • Uncoated knee femur prosthesis, metallic

Dukal - 10665973006007

Island Dressing 4" x 5"
Dukal LLC
4071
In Commercial Distribution

  • 20665973006004 ()
  • 10665973006007 ()
  • 30665973006001 ()
4071

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

CORE DYNAMICS - 10653405045786

5/10mm Flip Top Reducer
Conmed Corporation
CD511
In Commercial Distribution

  • 20653405045783 ()
  • 10653405045786 ()
  • 00653405045789 ()

  • 5/10 Millimeter Outer Diameter ENTREE Plus and ENTREEII Cannula
CD511

  • Laparoscopic access cannula anchor, reusable

Precision Point Locator - 00819409020348

Precision Point Locator (5 each)
Sientra, Inc.
PPL01
In Commercial Distribution

  • 00819409020348 ()

  • Not applicable
PPL01

  • Tissue expander injection port locator

REFLEX - 10653405035176

REFLEX 5/12MM UNIVERSAL CONVERTER
Conmed Corporation
1700
In Commercial Distribution

  • 10653405035176 ()
  • 20653405035173 ()

  • Universal Converter
1700

  • Laparoscopic access cannula seal reducer, single-use
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