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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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TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-exchange silver. TRITEC Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. TRITEC Silver is indicated for the management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). The dressings are contraindicated for patients with a known silver sensitivity. The dressing is white and the nylon side (side placed away from the wound) is printed with navy and a light blue. The navy print is a circle logo with"Milliken" above and "TRITEC Silver" printed inside. The dressing is also printed with navy "this side away from wound," as well as a light blue repeating set of symbols of an arrow, heart, and shield.
MILLIKEN HEALTHCARE PDTS, LLC
4x48"
In Commercial Distribution

  • 10015961292965 ()
  • 00015961292968 ()
  • 20015961292962 ()

  • Area/Surface Area: 192 Square inch
3000004575

  • Exudate-absorbent dressing, non-gel, antimicrobial
TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-exchange silver. TRITEC Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. TRITEC Silver is indicated for the management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). The dressings are contraindicated for patients with a known silver sensitivity. The dressing is white and the nylon side (side placed away from the wound) is printed with navy and a light blue. The navy print is a circle logo with"Milliken" above and "TRITEC Silver" printed inside. The dressing is also printed with navy "this side away from wound," as well as a light blue repeating set of symbols of an arrow, heart, and shield.
MILLIKEN HEALTHCARE PDTS, LLC
6x6
In Commercial Distribution

  • 10015961292958 ()
  • 00015961292951 ()
  • 20015961292955 ()

  • Area/Surface Area: 36 Square inch
3000004573

  • Exudate-absorbent dressing, non-gel, antimicrobial
TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-exchange silver. TRITEC Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. TRITEC Silver is indicated for the management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). The dressings are contraindicated for patients with a known silver sensitivity. The dressing is white and the nylon side (side placed away from the wound) is printed with navy and a light blue. The navy print is a circle logo with"Milliken" above and "TRITEC Silver" printed inside. The dressing is also printed with navy "this side away from wound," as well as a light blue repeating set of symbols of an arrow, heart, and shield.
MILLIKEN HEALTHCARE PDTS, LLC
4"x5"
In Commercial Distribution

  • 10015961292934 ()
  • 00015961292937 ()
  • 20015961292931 ()
  • 30015961292938 ()

  • Area/Surface Area: 20 Square inch
3000005137

  • Exudate-absorbent dressing, non-gel, antimicrobial
ULTRA Silver is a sterile, single use foam wound dressing. ULTRA Silver is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. ULTRA Silver dressings kill bacteria within the dressing and provides an antimicrobial barrier and reduces microbial penetration through the dressing. The dressing is contraindicated for patients with a known silver sensitivity. The dressing has a polyester/ nylon wound contact layer coated with an ion-exchange silver, polyurethane absorbent foam, and a moisture vapor permeable film outer layer. The film outer layer (side placed away from the wound) is tan printed with green. The print is a circle logo with "Milliken" above and "ULTRA Silver" printed inside. The dressing is also printed with "this side away from wound," as well as a repeating set of symbols of an arrow, heart, and shield.
MILLIKEN HEALTHCARE PDTS, LLC
8"x20"
In Commercial Distribution

  • 20015961649704 ()
  • 10015961649707 ()
  • 00015961649700 ()
3000112212

  • Exudate-absorbent dressing, non-gel, antimicrobial
TRITEC Silver is a sterile, single use polyester/nylon wound contact layer coated with an ion-exchange silver. TRITEC Silver dressings provide an antimicrobial barrier to microbial colonization in the dressing and reduce microbial penetration through the dressing. TRITEC Silver is indicated for the management of acute and chronic wounds: partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic). The dressings are contraindicated for patients with a known silver sensitivity. The dressing is white and the nylon side (side placed away from the wound) is printed with navy and a light blue. The navy print is a circle logo with"Milliken" above and "TRITEC Silver" printed inside. The dressing is also printed with navy "this side away from wound," as well as a light blue repeating set of symbols of an arrow, heart, and shield.
MILLIKEN HEALTHCARE PDTS, LLC
Pre-Cut 4"x5"
In Commercial Distribution

  • 10015961649684 ()
  • 00015961649687 ()
  • 20015961649681 ()
  • 30015961649688 ()

  • Area/Surface Area: 20 Square inch
3000112331

  • Exudate-absorbent dressing, non-gel, antimicrobial
ULTRA Silver is a sterile, single use foam wound dressing. ULTRA Silver is indicated for management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and stage I-IV vascular ulcers, pressure ulcers, venous ulcers, and diabetic ulcers. ULTRA Silver dressings kill bacteria within the dressing and provides an antimicrobial barrier and reduces microbial penetration through the dressing. The dressing is contraindicated for patients with a known silver sensitivity. The dressing has a polyester/ nylon wound contact layer coated with an ion-exchange silver, polyurethane absorbent foam, and a moisture vapor permeable film outer layer. The film outer layer (side placed away from the wound) is tan printed with green. The print is a circle logo with"Milliken" above and "ULTRA Silver" printed inside. The dressing is also printed with "this side away from wound," as well as a repeating set of symbols of an arrow, heart, and shield.
MILLIKEN HEALTHCARE PDTS, LLC
4"x5"
In Commercial Distribution

  • 20015961464376 ()
  • 10015961464379 ()
  • 00015961464372 ()
3000051018

  • Exudate-absorbent dressing, non-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 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
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
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
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