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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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Trel-XPress 300c, 2.5cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c25
In Commercial Distribution

  • 10381780112594 ()
  • M386XPRES3C251 ()

  • 2.5cc
XPres3c25

  • Bone matrix implant, human-derived
Trel-XPress 300c, 5cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c05
In Commercial Distribution

  • 10381780112587 ()
  • M386XPRES3C051 ()

  • 5cc
XPres3c05

  • Bone matrix implant, human-derived
Trel-XPress 300c, 10cc is made using demineralized human bone and cancellous chips mixed with poloxamer resorbable reverse phase medium. Trel-Xpress 300c is formulated into a putty form and is provided in a sterile, single use package.
Integra Lifesciences Corporation
XPres3c10
In Commercial Distribution

  • M386XPRES3C101 ()
  • 10381780112570 ()

  • 10cc
XPres3c10

  • Bone matrix implant, human-derived
GalaFLEX LITE scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100027-06
Not in Commercial Distribution

  • 00810054980599 ()

  • Outer Diameter: 8.9 Centimeter
GFLT0008

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-14
Not in Commercial Distribution

  • 00810054980391 ()

  • Outer Diameter: 7.6 Centimeter
SH3D14

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-13
Not in Commercial Distribution

  • 00810054980384 ()

  • Outer Diameter: 7.6 Centimeter
SH3D13

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-12
Not in Commercial Distribution

  • 00810054980377 ()

  • Height: 10.2 Centimeter
  • Width: 2.5 Centimeter
SH3D12

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-11
Not in Commercial Distribution

  • 00810054980360 ()

  • Height: 10.2 Centimeter
  • Width: 2.5 Centimeter
SH3D11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-10
Not in Commercial Distribution

  • 00810054980353 ()

  • Length: 2.5 Centimeter
  • Width: 7.6 Centimeter
SH3D10

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-09
Not in Commercial Distribution

  • 00810054980346 ()

  • Width: 7.6 Centimeter
  • Length: 2.5 Centimeter
SH3D09

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
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