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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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PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (3 mL)
3-D MATRIX INC.
651-008
In Commercial Distribution

  • 00860001820836 ()


  • Intranasal splint, biodegradable
PuraSinus Gel is a space-occupying gel stent intended to be used in nasal surgery (5 mL)
3-D MATRIX INC.
651-009
In Commercial Distribution

  • 00860001820829 ()


  • Intranasal splint, biodegradable
Abiomed Breethe OXY-1 PLU Disposable
Breethe, Inc.
1000140
In Commercial Distribution

  • 00860001797916 ()
001-0400-100

  • Extracorporeal membrane oxygenator
Sterile Bar Drape (BD92126)
STERIMED LLC
BD92126
In Commercial Distribution

  • 10860001790297 ()
  • 00860001790290 ()


  • Medical equipment/instrument drape, single-use
Equipment Drape 18" X 24"
STERIMED LLC
0888NT
In Commercial Distribution

  • 10860001790204 ()
  • 00860001790207 ()
0888NT

  • Medical equipment/instrument drape, single-use
Microlyte Ag VET Matrix, 4" x 4" (10 cm x 10 cm), Box of 5
IMBED BIOSCIENCES, INC.
99001
In Commercial Distribution

  • 00860001725759 ()

  • Area/Surface Area: 100 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Microlyte Ag VET Matrix, 2" x 2" (5 cm x 5 cm), Box of 5
IMBED BIOSCIENCES, INC.
99000
In Commercial Distribution

  • 00860001725742 ()

  • Area/Surface Area: 25 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
91002
In Commercial Distribution

  • 00860001725735 ()
  • B519910020 ()
  • 00860001725728 ()

  • Area/Surface Area: 100 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Microlyte® Matrix is a sterile, single use absorbent polymeric wound matrix composed primarily of polyvinyl alcohol with a polymeric surface coating containing ionic and metallic silver. It has very low amounts of silver, with a maximum of 0.16 mg/sqin. Microlyte® Matrix is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
91001
In Commercial Distribution

  • 00860001725711 ()
  • B519910010 ()
  • 00860001725704 ()

  • Area/Surface Area: 25 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
PharmChem, Inc. Transparent Overlay Film (4" x 5") with Cutout (1" x 1.65").
PHARMCHEM, INC.
Single Overlay
In Commercial Distribution

  • 10860001701064 ()
  • 00860001701067 ()
  • 00860001701012 ()


  • Adhesive bandage
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