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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Biologic Matrix
REPRISE BIOMEDICAL, INC.
BLM-100-01-1010
Not in Commercial Distribution

  • 00857072005026 ()

  • Width: 10 Centimeter
  • Height: 10 Centimeter


  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Biologic Matrix
REPRISE BIOMEDICAL, INC.
BLM-100-01-0808
Not in Commercial Distribution

  • 00857072005019 ()

  • Width: 8 Centimeter
  • Height: 8 Centimeter


  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Biologic Matrix
REPRISE BIOMEDICAL, INC.
BLM-100-01-0608
Not in Commercial Distribution

  • 00857072005002 ()

  • Height: 8 Centimeter
  • Width: 6 Centimeter


  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
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.
TELA BIO, INC.
R20252-1020G
In Commercial Distribution

  • 00856072005289 ()

  • Length: 10.5 Centimeter
  • Width: 20 Centimeter


  • Extra-gynaecological surgical mesh, biologic-polymer composite
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.
TELA BIO, INC.
R20253-1122G
Not in Commercial Distribution

  • 00856072005197 ()

  • Length: 11.5 Centimeter
  • Width: 22 Centimeter


  • Extra-gynaecological surgical mesh, biologic-polymer composite
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.
TELA BIO, INC.
R20243-1122P
In Commercial Distribution

  • 00856072005142 ()

  • Length: 11 Centimeter
  • Width: 22 Centimeter


  • Extra-gynaecological surgical mesh, biologic-polymer composite
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.
TELA BIO, INC.
R20243-1018P
In Commercial Distribution

  • 00856072005135 ()

  • Length: 10 Centimeter
  • Width: 18.5 Centimeter


  • Extra-gynaecological surgical mesh, biologic-polymer composite
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.
TELA BIO, INC.
R20153-2020G
Not in Commercial Distribution

  • 00856072005111 ()

  • Length: 20 Centimeter
  • Width: 20.5 Centimeter


  • Extra-gynaecological surgical mesh, biologic-polymer composite
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.
TELA BIO, INC.
R20153-1620G
Not in Commercial Distribution

  • 00856072005104 ()

  • Length: 16.5 Centimeter
  • Width: 20 Centimeter


  • Extra-gynaecological surgical mesh, biologic-polymer composite
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.
TELA BIO, INC.
R20143-2020P
In Commercial Distribution

  • 00856072005074 ()

  • Length: 20 Centimeter
  • Width: 20.5 Centimeter


  • Extra-gynaecological surgical mesh, biologic-polymer composite
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