OLYMPUS TERUMO BIOMATERIALS CORP.

Address:454-1 Higashino, Nagaizumi-cho,Sunto-gun Shizuoka,JP

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- Catalog Number : 27-500-200

Device Description : Collagen-Based Bone Filling Augmentation Material./Product Overview:FOUNDATION i Collagen-Based Bone Filling Augmentation Material./Product Overview:FOUNDATION is made of absorbable atelo-collagen. Theatelo-collagen has been cross-linked by heat treatmentin order to achieve biocompatibility. FOUNDATION isprovided in bullet shapes. The collagen (liquid form)suspension is pored into a bullet shape mold. The designof the bullet shape is to permit easy placement into theextraction socket. It consists of fibrillar and heat-denaturedatelo-collagen. Fibrillar atelo-collagen provides scaffoldingfor surrounding cells and the heat-denatured atelo-collagenstimulates infiltration of the cells in the product. Contents are sterile and non-pyrogenic.

Device Class : 2

Duns Number: 697730638

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

- Catalog Number : 27-500-100

Device Description : Collagen-Based Bone Filling Augmentation Material./Product Overview:FOUNDATION i Collagen-Based Bone Filling Augmentation Material./Product Overview:FOUNDATION is made of absorbable atelo-collagen. Theatelo-collagen has been cross-linked by heat treatmentin order to achieve biocompatibility. FOUNDATION isprovided in bullet shapes. The collagen (liquid form)suspension is pored into a bullet shape mold. The designof the bullet shape is to permit easy placement into theextraction socket. It consists of fibrillar and heat-denaturedatelo-collagen. Fibrillar atelo-collagen provides scaffoldingfor surrounding cells and the heat-denatured atelo-collagenstimulates infiltration of the cells in the product. Contents are sterile and non-pyrogenic.

Device Class : 2

Duns Number: 697730638

Premarket Exempt : No

Product Code : LYC

Prescription Use : Yes

Device Count : 1

- Catalog Number : AR-13370-1

Device Description : OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids.

Device Class : 2

Duns Number: 697730638

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : AR-13370-2

Device Description : OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids.

Device Class : 2

Duns Number: 697730638

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : AR-13370-3

Device Description : OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids.

Device Class : 2

Duns Number: 697730638

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : AR-13370-4

Device Description : OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids.

Device Class : 2

Duns Number: 697730638

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : AR-13372-1

Device Description : OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids.

Device Class : 2

Duns Number: 697730638

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : AR-13372-2

Device Description : OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids.

Device Class : 2

Duns Number: 697730638

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

- Catalog Number : AR-13372-3

Device Description : OSferion is a white porous material composed of β-tricalciumphosphate. It is int OSferion is a white porous material composed of β-tricalciumphosphate. It is intended to fill bony voids or gaps caused bytrauma or surgery that are not intrinsic to the stability of thebony structure. OSferion is to be used as a bone replacementmaterial and has properties that allow it to be replaced byautogenous bone after implantation.The porosity of OSferion is 60%.Products are supplied in wedges and trapezoids.

Device Class : 2

Duns Number: 697730638

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1