Nitinol Devices and Components, Inc.

Model HPSS35260- all lots.

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Stiff Shaft, Straight Tip, 260 CM Length; || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA; || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Model HPSS35180- all lots.

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

HydroFinity Hydrophilic guidewire; || 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA. || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Model HPSS35150- all lots.

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Stiff Shaft, Straight Tip, 150 CM Length; || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA. || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Model HPSA35260- all lots.

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Stiff Shaft, Angled Tip, 260 CM Length; || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA. || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.

Model HPSA35180- all lots.

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length; || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA || Manufactured in Costa Rica. || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.