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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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Surgaflex™ 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. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
SF0406
In Commercial Distribution

  • 00850019162196 ()

  • Area/Surface Area: 24 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Surgaflex™ 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. Surgaflex™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
SF0203
In Commercial Distribution

  • 00850019162189 ()

  • Area/Surface Area: 6 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
PelashieldAM™ 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. PelashieldAM™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
PS1515
In Commercial Distribution

  • 00850019162141 ()

  • Area/Surface Area: 225 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
PelashieldAM™ 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. PelashieldAM™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
PS1023
In Commercial Distribution

  • 00850019162134 ()

  • Area/Surface Area: 230 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
PelashieldAM™ 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. PelashieldAM™ is intended for the management of wounds. The device is packaged in sterile, sealed single pouches.
IMBED BIOSCIENCES, INC.
PS0523
In Commercial Distribution

  • 00850019162127 ()

  • Area/Surface Area: 115 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
WHIP-MIX CORPORATION
71174
In Commercial Distribution

  • D040711740 ()


  • Dental appliance fabrication material, resin
Whip Mix VeriSplint™ OS is a light-cured resin and sold as Rx only. It is a base polymer used to create removable structures for therapeutic restorations i.e., bite guards/splints and occlusal night guards/splints using the Additive Manufacturing process. The resin in combination with a scanner, printer, and curing unit make up the system.
WHIP-MIX CORPORATION
71147
Not in Commercial Distribution

  • D040711471 ()


  • Dental appliance fabrication material, resin
The StatGuard Hemostatic Dressing is composed of a non-woven gauze made of chitosan which is applied to an arterial or venous puncture or incision to promote post-procedure hemostasis and control of moderate to severe wound bleeding, exudates absorption, and coagulation. Model 3020-10 provides a 2 cm x 3.5 cm gauze, in a 4 cm x 6 cm adhesive dressing.
Semler Technologies, Inc.
3020-10
In Commercial Distribution

  • 10815614020811 ()
  • 20815614020818 ()
  • 30815614020815 ()
480-3020-10

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding. The device may be left in place for up to 72 hours.
MEDTRADE PRODUCTS LIMITED
FG05839331
In Commercial Distribution

  • 75060206631600 ()
  • 15060206631608 ()

  • Width: 3 Inch
  • Length: 5 Feet
  • 3inch x 5ft z-fold gauze
FG05839331

  • Chitosan haemostatic agent, professional, non-bioabsorbable
Celox Rapid X-Ray Gauze is a sterile, single-use hemostatic gauze for external use. The gauze is stitch-bonded with a radiopaque strip and coated in chitosan-based hemostatic granules. The device is intended to control bleeding by forming a gel-like plug at the site of bleeding. The device may be left in place for up to 72 hours.
MEDTRADE PRODUCTS LIMITED
FG08839251
In Commercial Distribution

  • 75060206631570 ()
  • 15060206631578 ()

  • Width: 3 Inch
  • Length: 5 Feet
  • 3inch x 5ft z-fold gauze
FG08839251

  • Chitosan haemostatic agent, professional, non-bioabsorbable
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