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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Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Mini 140 cc
Establishment Labs S.A.
SZM-140
In Commercial Distribution

  • 07445161009623 ()
SZM-140

  • Invasive breast implant sizer, fixed, single-use
Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Mini 125 cc
Establishment Labs S.A.
SZM-125
In Commercial Distribution

  • 07445161009616 ()
SZM-125

  • Invasive breast implant sizer, fixed, single-use
Intraoperative, Single Use, Sterile Silicone Breast Sizer Motiva Implant Matrix Round Sizer - Mini 105 cc
Establishment Labs S.A.
SZM-105
In Commercial Distribution

  • 07445161009609 ()
SZM-105

  • Invasive breast implant sizer, fixed, single-use
PORT LOCATOR Motiva Flora Port Locator
Establishment Labs S.A.
MFPL-001
In Commercial Distribution

  • 07445161009487 ()
MFPL-001

  • Tissue expander injection port locator
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
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
The Panthera Occlusal Appliance is indicated for protection of teeth and restorations from the forces and damage of parafunctions like bruxism, prevention of noise associated with bruxism, and for alleviation of temporomandibular joint, muscle and tension headache pains associated with temporomandibular disorders.
Panthera Dentaire Inc
1
In Commercial Distribution

  • 07540204000077 ()


  • Removable dental occlusal splint, custom-made
Hemostatic Gauze (4x4")
VIVE HEALTH LLC
RHB3030S10CT
In Commercial Distribution

  • 10810113578511 ()
  • 00810113578514 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Hemostatic Gauze (2x2")
VIVE HEALTH LLC
RHB3030S10CT
In Commercial Distribution

  • 10810113578504 ()
  • 00810113578507 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Xeroform Petrolatum Dressing (5x9") 25ct
VIVE HEALTH LLC
RHB3028YEL59CT25
In Commercial Distribution

  • 10810113578115 ()
  • 00810113578118 ()


  • Petrolatum woven gauze pad
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