telabio.comOviTex PRS (Long-Term Resorbable)
TELA Bio, Inc.
TELA BIO, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010513348 | 3010513348 | TELA BIO, INC. | 1 | Y | 2026-01-01 | 1 GREAT VALLEY PKWY STE 24 Malvern PA US 19355 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810055070183 | OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery. | 1-844-835-2246 | customerservice@telabio.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 179006 | 2008708342 | K250598 | Endoform Reconstructive Template - PLGA | FTM | 2025-06-03 |
| 179006 | 1342036772 | K243595 | OviTex PRS (Long-Term Resorbable) | FTM | 2024-12-19 |
| 179006 | 1895894969 | K241126 | OviTex PRS | FTM | 2024-05-22 |
| 179006 | 1953901318 | K214070 | OviTex PRS (Long Term Resorbable) | FTM | 2023-03-21 |
| 179006 | 1106167016 | K183398 | Endoform Restella | FTM | 2019-04-11 |
| 179006 | 1949664171 | K181935 | Endoform Reconstructive Template - Non Absorbable | FTL | 2018-12-04 |
| 179006 | 1387778333 | K153633 | Endoform Reconstructive Template | FTM | 2016-03-15 |
| 179006 | 1285037291 | K153632 | Endoform Reconstructive Template | FTL | 2016-06-16 |
| 179006 | 1450037167 |
Product Codes Associated With Registrations#
PMN#
OviTex PRS
TELA Bio, Inc.
OviTex PRS (Long Term Resorbable)
Tela Bio
OVINE TISSUE MATRIX(OTM)
TELA BIO, INC.
GUDID#
OviTex® - 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.
2026-03-27
OviTex® - 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.
2025-12-05
OviTex® - 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.
2025-08-06
OviTex® - 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.
2025-07-08
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2023-07-12
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2023-07-12
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2023-07-12
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2023-07-12
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2023-07-12
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2023-07-12
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2025-02-21
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2025-02-21
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2025-02-21
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2022-01-04
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2020-09-14
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2020-09-14
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2020-09-14
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2020-05-15
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2020-05-15
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2020-05-15
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2020-05-15
OviTex® PRS - The OviTex® PRS Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery.
2020-05-15
OviTex® - 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.
2024-10-15
OviTex® - 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.
2024-08-19
OviTex® - 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.
2024-06-07
OviTex® PRS - 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.
2020-09-14
OviTex® PRS - 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.
2020-09-14
OviTex® PRS - 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.
2020-09-14
OviTex® - 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.
2024-01-09
OviTex® - 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.
2024-01-09
OviTex® - 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.
2024-01-09
OviTex® - 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.
2022-06-21
OviTex® - 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.
2022-06-21
TELAMax - 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.
2015-09-17
TELAMax 1S - 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.
2015-09-17
TELAMax - 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.
2015-09-17
OviTex® - 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.
2022-05-17
OviTex® - 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.
2022-04-26
OviTex® - 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.
2022-04-26
OviTex® - 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.
2022-03-28