Lot number: 07NP181 Exp June 2010

General and Plastic Surgery Devices

Nationwide Korea, Taiwan, Japan

Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier). Japan Distribution Only || Product Number: 4301-05

Lot Numbers:  07NP135 Exp Date: April 2010; 07NP177 Exp Date: May 2010;  07NP199 Exp Date: June 2010;  07NP216 Exp. Date: July 2010;  07NP311 Exp. Date: May 2010

General and Plastic Surgery Devices

Nationwide Korea, Taiwan, Japan

Seprafilm Adhesion Barrier (chemically modified sodium hyaluronate/carboxymethylcellulose absorbable adhesion barrier) || Product Number: 4301-02

Worldwide distribution.

Diamigo i-Phone App || The Diamigo app was intended for use as an educational tool in the management of diabetes.

Model Catalog: (Lot serial: )

OPTIPEN PRO

Model Catalog: (Lot serial: "AA" THROUGH "SI"); Model Catalog: (Lot serial: "A" THROUGH "S"); Model Catalog: (Lot serial: ALL)

ONE TOUCH ULTRA BLOOD GLUCOSE MONITOR

medical_device

see letter | all

MD: Intravascular occluding solution kit

LeGoo Endovascular Occlusion Gel

Disposable products

Model Catalog: (Lot serial: ALL LOT NUMBERS)

ICY HOT HEAT THERAPY

Reagent lot Number 491686, Lot #7EP027 exp 01/15/09

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution

Equal Diagnostics Lipase Color Reagent Kit || Part Number: 905-D || For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .

Reagent lot Number 491686, Lot #: 7EPM30 exp 01/15/09

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution

Equal Diagnostics Lipase Color Reagent Kit || Part Number: 905-B || For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 80-2005-01.

Reagent lot Number 491686, Lot #7EPN32 Exp 01/15/09

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution

Equal Diagnostics Lipase Color Reagent Kit || Part Number: 905-C || For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .

Reagent lot Number 491686, Lot #7EPP31 exp 01/15/09

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution

Equal Diagnostics Lipase Color Reagent Kit || Part Number: 905-E || For In Vitro Diagnostic Use Containing the Lipase Color Reagent, 30 ml, Part Number 2005-01, lot Number 491686 .

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

LeGoo Internal Vessel Occluder 5mL || Product Number: 10-0500 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

LeGoo Internal Vessel Occluder 2.5mL || Product Number: 10-0250 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

LeGoo Internal Vessel Occluder .25mL || Product Number: 10-0025 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

LeGoo Internal Vessel Occluder 1mL || Product Number: 10-0100 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

LeGoo Internal Vessel Occluder 10mL || Product Number: 10-1000 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo w/ no Cannula || Product Number: PV-250 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

LeGoo¿ Endovascular Occlusion Gel-2.5 mL LeGoo with 1 Cannula Pouch || Product Number: LG250 || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.

All lot codes

Cardiovascular Devices

3

No

Worldwide Distribution - USA (nationwide) and internationally to Austria, Belgium, Canada, Denmark, Egypt. Europe, Finland, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Poland, Saudi Arabia, Slovena, Spain, Sweden, Switzerland, The Netherlands, Turkey, and UK.

LeGoo Endovascular Occlusion Gel 2.5 mL || Product Number: LG250IT || LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for temporary endovascular occlusion of blood vessels up to 4 mm in diameter below the neck.