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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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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 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 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 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
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
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Hologic, Inc.
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In Commercial Distribution

  • 25420045506951 ()


  • Radiological breast positioner, non-wearable
No Description
Merit Medical Systems, Inc.
00884450333761
In Commercial Distribution

  • 00884450333761 ()
K12T-09907

  • General surgical procedure kit, non-medicated, single-use
No Description
Merit Medical Systems, Inc.
00884450333754
In Commercial Distribution

  • 00884450333754 ()
K12T-09477B

  • General surgical procedure kit, non-medicated, single-use
No Description
Merit Medical Systems, Inc.
00884450333747
In Commercial Distribution

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

  • Catheter/overtube balloon inflator, single-use
No Description
Merit Medical Systems, Inc.
00884450333730
In Commercial Distribution

  • 00884450333730 ()
K09T-10728F

  • Contrast medium injection system administration set
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