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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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GalaSHAPE 3D - 00855920006454

GalaSHAPE 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.
100042-24
In Commercial Distribution

  • 00855920006454 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CESH04

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaSHAPE 3D - 00855920006430

GalaSHAPE 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.
100042-22
In Commercial Distribution

  • 00855920006430 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CESH02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980537

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.
100042-34
In Commercial Distribution

  • 00810054980537 ()

  • Outer Diameter: 7.6 Centimeter
CESH14

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980520

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.
100042-33
In Commercial Distribution

  • 00810054980520 ()

  • Outer Diameter: 7.6 Centimeter
CESH13

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980513

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.
100042-32
In Commercial Distribution

  • 00810054980513 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CESH12

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980506

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.
100042-31
In Commercial Distribution

  • 00810054980506 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CESH11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980490

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.
100042-30
In Commercial Distribution

  • 00810054980490 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CESH10

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980483

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.
100042-29
In Commercial Distribution

  • 00810054980483 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CESH09

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980476

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.
100042-28
In Commercial Distribution

  • 00810054980476 ()

  • Width: 20.3 Centimeter
  • Height: 7.6 Centimeter
CESH08

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980469

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.
100042-27
In Commercial Distribution

  • 00810054980469 ()

  • Width: 20.3 Centimeter
  • Height: 7.6 Centimeter
CESH07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980452

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.
100042-26
In Commercial Distribution

  • 00810054980452 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CESH06

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980445

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.
100042-25
In Commercial Distribution

  • 00810054980445 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CESH05

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980438

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.
100042-24
In Commercial Distribution

  • 00810054980438 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CESH04

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980421

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.
100042-23
In Commercial Distribution

  • 00810054980421 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CESH03

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980414

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.
100042-22
In Commercial Distribution

  • 00810054980414 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CESH02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980407

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.
100042-21
In Commercial Distribution

  • 00810054980407 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CESH01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980254

GalaFLEX 3DR 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.
100043-34
In Commercial Distribution

  • 00810054980254 ()

  • Outer Diameter: 7.6 Centimeter
CEFR14

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980247

GalaFLEX 3DR 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.
100043-33
In Commercial Distribution

  • 00810054980247 ()

  • Outer Diameter: 7.6 Centimeter
CEFR13

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980230

GalaFLEX 3DR 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.
100043-32
In Commercial Distribution

  • 00810054980230 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CEFR12

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980223

GalaFLEX 3DR 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.
100043-31
In Commercial Distribution

  • 00810054980223 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CEFR11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980216

GalaFLEX 3DR 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.
100043-30
In Commercial Distribution

  • 00810054980216 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CEFR10

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980209

GalaFLEX 3DR 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.
100043-29
In Commercial Distribution

  • 00810054980209 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CEFR09

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980193

GalaFLEX 3DR 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.
100043-27
In Commercial Distribution

  • 00810054980193 ()

  • Width: 20.3 Centimeter
  • Height: 7.6 Centimeter
CEFR07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980186

GalaFLEX 3DR 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.
100043-26
In Commercial Distribution

  • 00810054980186 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CEFR06

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980179

GalaFLEX 3DR 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.
100043-25
In Commercial Distribution

  • 00810054980179 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CEFR05

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980162

GalaFLEX 3DR 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.
100043-24
In Commercial Distribution

  • 00810054980162 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CEFR04

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980155

GalaFLEX 3DR 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.
100043-23
In Commercial Distribution

  • 00810054980155 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CEFR03

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980148

GalaFLEX 3DR 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.
100043-22
In Commercial Distribution

  • 00810054980148 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CEFR02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980131

GalaFORM 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.
100043-21
In Commercial Distribution

  • 00810054980131 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CEFR01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

test - 25420045506951

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Hologic, Inc.
test
In Commercial Distribution

  • 25420045506951 ()


  • Radiological breast positioner, non-wearable

Merit Medical® - 00884450333761

No Description
Merit Medical Systems, Inc.
00884450333761
In Commercial Distribution

  • 00884450333761 ()
K12T-09907

  • General surgical procedure kit, non-medicated, single-use

Merit Medical® - 00884450333754

No Description
Merit Medical Systems, Inc.
00884450333754
In Commercial Distribution

  • 00884450333754 ()
K12T-09477B

  • General surgical procedure kit, non-medicated, single-use

Merit Medical® - 00884450333747

No Description
Merit Medical Systems, Inc.
00884450333747
In Commercial Distribution

  • 20884450333741 ()
  • 10884450333744 ()
  • 00884450333747 ()
K05-03041

  • Catheter/overtube balloon inflator, single-use

Merit Medical® - 00884450333730

No Description
Merit Medical Systems, Inc.
00884450333730
In Commercial Distribution

  • 00884450333730 ()
K09T-10728F

  • Contrast medium injection system administration set

Merit Medical® - 00884450333723

No Description
Merit Medical Systems, Inc.
00884450333723
In Commercial Distribution

  • 10884450333720 ()
  • 00884450333723 ()
  • 20884450333727 ()


  • Contrast medium injection system administration set

Merit Medical® - 00884450333716

No Description
Merit Medical Systems, Inc.
00884450333716
In Commercial Distribution

  • 10884450333713 ()
  • 00884450333716 ()
  • 20884450333710 ()


  • Basic intravenous administration set, noninvasive

AccessPLUS™ - 00884450333693

No Description
Merit Medical Systems, Inc.
00884450333693
In Commercial Distribution

  • 10884450333690 ()
  • 00884450333693 ()
  • 20884450333697 ()
MAP152/B

  • Angiography kit
  • Haemostasis valve

Merit Medical® - 00884450333686

No Description
Merit Medical Systems, Inc.
00884450333686
In Commercial Distribution

  • 00884450333686 ()
K12T-09916

  • General surgical procedure kit, non-medicated, single-use

Merit Medical® - 00884450333679

No Description
Merit Medical Systems, Inc.
00884450333679
In Commercial Distribution

  • 00884450333679 ()
K12T-09701B

  • General surgical procedure kit, non-medicated, single-use

Merit Medical® - 00884450333662

No Description
Merit Medical Systems, Inc.
00884450333662
In Commercial Distribution

  • 00884450333662 ()


  • General surgical procedure kit, non-medicated, single-use
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