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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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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
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 box of 5.
IMBED BIOSCIENCES, INC.
91018
In Commercial Distribution

  • 00850019162295 ()


  • 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.
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
Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
4 cc
In Commercial Distribution

  • 00860471002572 ()
CP-0040

  • Collagen wound matrix dressing
Corplex P is derived from human umbilical cord extracellular matrix (ECM) and is indicated for the management of a range of acute and chronic wounds. As a resorbable particulate device, Corplex P/Theracor P/Allacor P is lyophilized and packaged in a sterile vial, allowing the device to be rehydrated and applied directly to the wound.
Stimlabs LLC
2 cc
In Commercial Distribution

  • 00860471002565 ()
CP0020

  • Collagen wound matrix dressing
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.
SF0420
In Commercial Distribution

  • 00850019162202 ()

  • Area/Surface Area: 80 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
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