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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 scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100035-29
Not in Commercial Distribution

  • 00855920006072 ()

  • Width: 7.7 Centimeter
  • Length: 14 Centimeter
GP019S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100035-22
Not in Commercial Distribution

  • 00855920006065 ()

  • Width: 11.8 Centimeter
  • Length: 26 Centimeter
GP016M

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
GalaFLEX scaffold is a bioresorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB).
Tepha, Inc.
100035-23
Not in Commercial Distribution

  • 00855920006058 ()

  • Width: 10 Centimeter
  • Length: 22 Centimeter
GP016S

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
The standard bone awl is required for making the first mark.
OSTEOTEC LIMITED
OSTF-AWL
In Commercial Distribution

  • 05060183094604 ()
OSTF-AWL

  • Bone file/rasp, manual, reusable
The Sterilizable Handle is used with the HarmonyAIR A-Series Lighting System.
STERIS CORPORATION
A-Series Sterilizable Lighthandle
In Commercial Distribution

  • 00724995182410 ()
LAS0027

  • Medical equipment handle cover, reusable
The MISO bracket is indicated for orthodontic movement of natural teeth
HT Co., Ltd.
MB221-202
In Commercial Distribution

  • 08800022212908 ()
  • 08800022200035 ()
  • 08800022212915 ()
MB221-202

  • Orthodontic bracket, ceramic
The MISO bracket is indicated for orthodontic movement of natural teeth
HT Co., Ltd.
MB221-101
In Commercial Distribution

  • 08800022212885 ()
  • 08800022200004 ()
  • 08800022212892 ()
MB221-101

  • Orthodontic bracket, ceramic
The MISO bracket is indicated for orthodontic movement of natural teeth
HT Co., Ltd.
MB181-355
In Commercial Distribution

  • 08800022212878 ()
  • 08800022212861 ()
  • 08800022200561 ()
Roth 018 LR5H

  • Orthodontic bracket, ceramic
The MISO bracket is indicated for orthodontic movement of natural teeth
HT Co., Ltd.
MB181-455
In Commercial Distribution

  • 08800022212854 ()
  • 08800022212847 ()
  • 08800022200578 ()
Roth 018 LL5H

  • Orthodontic bracket, ceramic
The MISO bracket is indicated for orthodontic movement of natural teeth
HT Co., Ltd.
MB181-444
In Commercial Distribution

  • 08800022212830 ()
  • 08800022212823 ()
  • 08800022200530 ()
Roth 018 LL4H

  • Orthodontic bracket, ceramic
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