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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.
100043-30
In Commercial Distribution

  • 00810054980216 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CEFR10

  • 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.
100043-29
In Commercial Distribution

  • 00810054980209 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CEFR09

  • 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.
100043-27
In Commercial Distribution

  • 00810054980193 ()

  • Width: 20.3 Centimeter
  • Height: 7.6 Centimeter
CEFR07

  • 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.
100043-26
In Commercial Distribution

  • 00810054980186 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CEFR06

  • 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.
100043-25
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
test
Hologic, Inc.
test
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
No Description
Merit Medical Systems, Inc.
00884450333723
In Commercial Distribution

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


  • Contrast medium injection system administration set
No Description
Merit Medical Systems, Inc.
00884450333716
In Commercial Distribution

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


  • Basic intravenous administration set, noninvasive
No Description
Merit Medical Systems, Inc.
00884450333693
In Commercial Distribution

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

  • Angiography kit
  • Haemostasis valve
No Description
Merit Medical Systems, Inc.
00884450333686
In Commercial Distribution

  • 00884450333686 ()
K12T-09916

  • General surgical procedure kit, non-medicated, single-use
No Description
Merit Medical Systems, Inc.
00884450333679
In Commercial Distribution

  • 00884450333679 ()
K12T-09701B

  • General surgical procedure kit, non-medicated, single-use
No Description
Merit Medical Systems, Inc.
00884450333662
In Commercial Distribution

  • 00884450333662 ()


  • General surgical procedure kit, non-medicated, single-use
No Description
Merit Medical Systems, Inc.
00884450333648
In Commercial Distribution

  • 20884450333642 ()
  • 10884450333645 ()
  • 00884450333648 ()
C408655

  • General surgical procedure kit, non-medicated, single-use
No Description
Merit Medical Systems, Inc.
00884450333631
In Commercial Distribution

  • 10884450333638 ()
  • 00884450333631 ()
  • 20884450333635 ()


  • General surgical procedure kit, non-medicated, single-use
No Description
Merit Medical Systems, Inc.
00884450333549
In Commercial Distribution

  • 00884450333549 ()
K10T-05628

  • Closed-wound/centesis drainage receptacle
No Description
Merit Medical Systems, Inc.
00884450333518
In Commercial Distribution

  • 10884450333515 ()
  • 00884450333518 ()
  • 20884450333512 ()
K13-00818A

  • Procedural medication labelling set
No Description
Merit Medical Systems, Inc.
00884450333501
In Commercial Distribution

  • 10884450333508 ()
  • 00884450333501 ()
  • 20884450333505 ()


  • Closed-wound/centesis drainage receptacle
No Description
Merit Medical Systems, Inc.
00884450333495
In Commercial Distribution

  • 00884450333495 ()
K12T-09920

  • General surgical procedure kit, non-medicated, single-use
No Description
Merit Medical Systems, Inc.
00884450333464
In Commercial Distribution

  • 00884450333464 ()
K10T-00554H

  • Closed-wound/centesis drainage receptacle
No Description
Merit Medical Systems, Inc.
00884450333457
In Commercial Distribution

  • 20884450333451 ()
  • 10884450333454 ()
  • 00884450333457 ()
K09-10950B

  • Contrast medium injection system administration set
No Description
Merit Medical Systems, Inc.
00884450333426
In Commercial Distribution

  • 20884450333420 ()
  • 10884450333423 ()
  • 00884450333426 ()

  • Coaxial Gauge-19G
  • Coaxial Length (cm)-14.6 cm
CORC2020B/A

  • Soft-tissue biopsy procedure kit, non-medicated
No Description
Merit Medical Systems, Inc.
00884450333419
In Commercial Distribution

  • 10884450333416 ()
  • 00884450333419 ()
  • 20884450333413 ()

  • Coaxial Gauge-19G
  • Coaxial Length (cm)-9.6 cm
CORC2015B/A

  • Soft-tissue biopsy procedure kit, non-medicated
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