TELA BIO, INC.

Address:1 GREAT VALLEY PKWY STE 24,Malvern,PA,19355,US

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Device Description : The Shaped Cutting Template is a reusable stainless steel surgical instrument. T The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.

Device Class : 1

Duns Number: 078721472

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Shaped Cutting Template is a reusable stainless steel surgical instrument. T The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.

Device Class : 1

Duns Number: 078721472

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Shaped Cutting Template is a reusable stainless steel surgical instrument. T The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.

Device Class : 1

Duns Number: 078721472

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Shaped Cutting Template is a reusable stainless steel surgical instrument. T The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.

Device Class : 1

Duns Number: 078721472

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Shaped Cutting Template is a reusable stainless steel surgical instrument. T The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.

Device Class : 1

Duns Number: 078721472

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

- Catalog Number :

Device Description : The Shaped Cutting Template is a reusable stainless steel surgical instrument. T The Shaped Cutting Template is a reusable stainless steel surgical instrument. The Shaped Cutting Template is intended to allow users to trace and cut specific shapes of implantable materials, such as the OviTex Reinforced Tissue Matrix.

Device Class : 1

Duns Number: 078721472

Premarket Exempt : Yes

Product Code : FZX

Prescription Use : Yes

Device Count : 1

- Catalog Number : F10068-1010

Device Description : TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. TELAMax will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.

Device Class : 2

Duns Number: 078721472

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

- Catalog Number : F10069-1822

Device Description : TELAMax 1S is a sterile bioscaffold composed of ovine (sheep) derived extracellu TELAMax 1S is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. The device consists of two sides: a textured and smooth side. The textured side of the device, indicated with blue polypropylene, provides a surface conducive for tissue ingrowth. The smooth side of the device, containing clear polypropylene, provides a surface designed to minimize tissue attachment. TELAMax 1S will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax 1S is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.

Device Class : 2

Duns Number: 078721472

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1

- Catalog Number : F10068-0408

Device Description : TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular TELAMax is a sterile bioscaffold composed of ovine (sheep) derived extracellular matrix (ECM) and monofilament polypropylene. TELAMax will incorporate into the recipient tissue with associated cellular and microvascular ingrowth. TELAMax is provided in various shapes and sizes to suit surgeon preference and the complexity of the soft tissue repair. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.

Device Class : 2

Duns Number: 078721472

Premarket Exempt : No

Product Code : FTM

Prescription Use : Yes

Device Count : 1