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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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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.
AROA BIOSURGERY LIMITED
R30353-1622G
Not in Commercial Distribution

  • 09421905067140 ()


  • 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
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
he PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units.
INVUITY, INC.
PB1
In Commercial Distribution

  • 00816728021094 ()
PB1

  • Open-surgery electrosurgical electrode, monopolar, single-use
he PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units.
INVUITY, INC.
PB1
In Commercial Distribution

PB1

  • Open-surgery electrosurgical electrode, monopolar, single-use
The PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units.
STRYKER CORPORATION
PB1
In Commercial Distribution

  • 00816728020158 ()
PB1

  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
Trel-X™Gel, 10cc is human bone that has been demineralized and combined with poloxamer reverse phase medium which is formulated into a gel or putty-like form. Trel-X is provided in a sterile, single patient use package.
Integra Lifesciences Corporation
TXG10
In Commercial Distribution

  • M386TXG101 ()
  • 10381780114369 ()

  • 10cc
TXG10

  • Bone matrix implant, human-derived
Trel-X™Gel, 5cc is human bone that has been demineralized and combined with poloxamer reverse phase medium which is formulated into a gel or putty-like form. Trel-X is provided in a sterile, single patient use package.
Integra Lifesciences Corporation
TXG05
In Commercial Distribution

  • M386TXG051 ()
  • 10381780112501 ()

  • 5cc
TXG05

  • Bone matrix implant, human-derived
Trel-X™Gel, 1cc is human bone that has been demineralized and combined with poloxamer reverse phase medium which is formulated into a gel or putty-like form. Trel-X is provided in a sterile, single patient use package.
Integra Lifesciences Corporation
TXG01
In Commercial Distribution

  • M386TXG011 ()
  • 10381780112495 ()

  • 1cc
TXG01

  • Bone matrix implant, human-derived
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