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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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SIENTRA Tissue Expander - 00812790022625

Tissue Expander, Rectangular, 3-Valves, Smooth, 200 ml
Sientra, Inc.
810-200U3
Not in Commercial Distribution

  • 00812790022625 ()

  • Total Volume: 200 Milliliter
810-200U3

  • Skin-port tissue expander

SIENTRA Tissue Expander - 00812790022601

Tissue Expander, Rectangular, 3-Valves, Smooth, 105 ml
Sientra, Inc.
810-105U3
Not in Commercial Distribution

  • 00812790022601 ()

  • Total Volume: 105 Milliliter
810-105U3

  • Skin-port tissue expander

SIENTRA Tissue Expander - 00812790022588

Tissue Expander, Rectangular, 3-Valves, Smooth, 50 ml
Sientra, Inc.
810-050U3
Not in Commercial Distribution

  • 00812790022588 ()

  • Total Volume: 50 Milliliter
810-050U3

  • Skin-port tissue expander

SIENTRA Tissue Expander - 00812790022571

Tissue Expander, Rectangular, 3-Valves, Smooth, 30 ml
Sientra, Inc.
810-030U3
Not in Commercial Distribution

  • 00812790022571 ()

  • Total Volume: 30 Milliliter
810-030U3

  • Skin-port tissue expander

SIENTRA Tissue Expander - 00812790022557

Tissue Expander, Calf, 1-Valve, Smooth, 145 ml
Sientra, Inc.
880-145U1
Not in Commercial Distribution

  • 00812790022557 ()

  • Total Volume: 145 Milliliter
880-145U1

  • Skin-port tissue expander

SIENTRA Tissue Expander - 00812790022533

Tissue Expander, Crescent, Magnetic Valve, Smooth, 400 ml
Sientra, Inc.
829-400U
Not in Commercial Distribution

  • 00812790022533 ()

  • Total Volume: 400 Milliliter
829-400U

  • Skin-port tissue expander

CARDINAL HEALTH - 00888499001360

Hydrogel Partial to full thickness wounds: -Pressure and stasis ulcers -First- and second-degree burns -Lacerations, cuts, and abrasions -Post-operative incisions -Skin irritations Excellent viscosity Clean, greaseless formulation Cardinal Health Hydrogel is a clean, greaseless hydrogel used for the maintenance of a moist wound environment. Indications: May be used for the management of dry to lightly exuding, partial and full thickness wounds, including pressure and stasis ulcers, first- and second-degree burns, lacerations, cuts, abrasions, skin irritations, post-operative incisions, and conditions with periostomal care. Directions for use: Cleanse wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Apply gel approximately 1/4-inch thick to wound bed. Cover with an appropriate secondary dressing. Repeat as often as necessary to keep wound moist. Ingredients: Water, aloe barbadensis leaf juice, glycerin, sorbitol, carbomer, triethanolamine, allantoin, methylparaben, disodium EDTA, imidazolidinyl urea Caution: For external use only. Avoid contact with eyes. If condition worsens or does not improve within 10 to 14 days, consult a physician. In rare instances of local sensitivity, discontinue use. Keep this and all similar products out of the reach of children. If swallowed, seek medical attention or contact a poison control center immediately. Follow directions for use. Store at ambient temperature.
Cardinal Health 200, LLC
HG3OZ
In Commercial Distribution

  • 10888499001367 ()
  • 00888499001360 ()
  • 00885380171874 ()
HG3OZ

  • Wound hydrogel dressing, non-sterile

CARDINAL HEALTH - 00888499001353

Hydrogel Excellent viscosity Clean, greaseless formulation Indications: Use for partial to full thickness wounds, including pressure and stasis ulcers, first- and second-degree burns, lacerations, cuts, abrasions, skin irritations, post-operative incisions, and conditions with periostomal care. Directions for use: Cleanse wound with appropriate wound cleanser such as Cardinal Health Wound Cleanser. Apply gel approximately 1/4-inch thick to wound bed. Cover with an appropriate secondary dressing. Repeat as often as necessary to keep wound moist. Caution: If condition worsens or does not improve within 10 to 14 days, consult a physician. For external use only. Ingredients: Water, aloe barbadensis leaf juice, glycerin, sorbitol, carbomer, triethanolamine, allantoin, methylparaben, disodium EDTA, imidazolidinyl urea Store at ambient temperature.
Cardinal Health 200, LLC
HG1OZ
In Commercial Distribution

  • 10888499001350 ()
  • 00888499001353 ()
HG1OZ

  • Wound hydrogel dressing, non-sterile

CARDINAL HEALTH - 00888499001346

Wound Cleanser No-rinse, non-irritating formulation Non-ionic surfactant Directions for use: 1. Turn nozzle to stream or spray position. 2. Spray contents on area to be cleansed approximately 3 inches away. Ingredients: Purified water, poloxamer 188, sodium bicarbonate, sorbitol, citric acid, disodium EDTA, methylparaben, imidazolidinyl urea Indications: May be used for the removal of foreign materials such as dirt and debris from dermal wounds. Caution: For external use only. Keep this and all similar products out of the reach of children. Store at ambient temperature.
Cardinal Health 200, LLC
WC8OZ
In Commercial Distribution

  • 10888499001343 ()
  • 00888499001346 ()
  • 00885380171867 ()
WC8OZ

  • Skin detergent

CARDINAL HEALTH - 00888499001049

WOUND GEL SILVER HYDROGEL ANTIMICROBIAL
Cardinal Health 200, LLC
HG15OZAG
In Commercial Distribution

  • 20888499001043 ()
  • 00888499001049 ()
  • 30888499001040 ()
HG15OZAG

  • Wound hydrogel dressing, antimicrobial
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