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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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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
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.
ML1010
In Commercial Distribution

  • 00850019162110 ()

  • 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.
ML0505
In Commercial Distribution

  • 00850019162103 ()

  • 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.
91008
In Commercial Distribution

  • 00850019162059 ()


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Microlyte Matrix, 6" x 6" (15 cm x 15 cm), Box of 5
IMBED BIOSCIENCES, INC.
91008
In Commercial Distribution

  • 00850019162042 ()

  • Area/Surface Area: 225 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.
91007
In Commercial Distribution

  • 00850019162035 ()


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
Microlyte Matrix, 4" x 9" (10 cm x 23 cm), Box of 5
IMBED BIOSCIENCES, INC.
91007
In Commercial Distribution

  • 00850019162028 ()

  • Area/Surface Area: 230 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
MicroLyte Matrix, 2" x 9" (5cm x 23 cm), Box of 5
IMBED BIOSCIENCES, INC.
91006
In Commercial Distribution

  • 00850019162004 ()

  • Area/Surface Area: 115 Square centimeter


  • Exudate-absorbent first aid dressing, hydrophilic-gel, antimicrobial
CellerateRX is Type I bovine hydrolyzed collagen gel for chronic and acute wounds including partial and full-thickness wounds, pressure injuries 1-4, venous stasis ulcers, arterial ulcers, diabetic ulcers, surgical wounds, traumatic wounds, first and second-degree burns, and superficial wounds. Sterile until opened. Store at room temperature. For use in management of lightly to moderately exudative wounds. Cleanse the wound per facility protocol. Apply CellerateRX over the entire wound bed and the edges of the wound. Cover with an appropriate dressing. Reapply CellerateRX a minimum of 2-3 times per week, or with each dressing change, taking care not to disrupt the wound site. www.sanaramedtech.com.
APPLIED NUTRITIONALS, LLC
CRXG-28GMEA
In Commercial Distribution

  • 00850019972092 ()


  • Collagen wound matrix dressing
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