TELA BIO, INC.

OviTex® PRS - 00856072005135 Catalog Number :

Device Description : OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Device Class : 2

Duns Number: 078721472

Premarket Exempt : No

Product Code : FTM, FTL

Prescription Use : Yes

Device Count : 1

OviTex® PRS - 00856072005142 Catalog Number :

Device Description : OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Device Class : 2

Duns Number: 078721472

Premarket Exempt : No

Product Code : FTM, FTL

Prescription Use : Yes

Device Count : 1

OviTex® PRS - 00856072005197 Catalog Number :

Device Description : OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Device Class : 2

Duns Number: 078721472

Premarket Exempt : No

Product Code : FTM, FTL

Prescription Use : Yes

Device Count : 1

OviTex® - 00856072005272 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

OviTex® PRS - 00856072005289 Catalog Number :

Device Description : OviTex® PRS is for implantation to reinforce soft tissue where weakness exists i OviTex® PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Device Class : 2

Duns Number: 078721472

Premarket Exempt : No

Product Code : FTM, FTL

Prescription Use : Yes

Device Count : 1

OviTex® - 00856072005531 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

OviTex® - 00856072005548 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

OviTex® - 00856072005555 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

OviTex® - 00856072005562 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

OviTex® - 00856072005579 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

TELA BIO, INC.

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