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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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The Proximal Phalanx Total Trial is used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL89030PPT
In Commercial Distribution

  • M269TRL89030PPT1 ()
  • 10381780236924 ()

  • Size 30; .721 in L x .520 in W (head); .433 in L (stem)


  • Surgical implant template, reusable
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
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
CUSA® Clarity Footswitch
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7002
In Commercial Distribution

  • 10381780126256 ()
C7002

  • Foot-switch, electrical
CUSA® Clarity Custom Cart
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7001
In Commercial Distribution

  • 10381780126249 ()
C7001

  • Electromechanical device/system transport trolley
CUSA® Clarity Ultrasonic Surgical Aspirator System
INTEGRA LIFESCIENCES (IRELAND) LIMITED
C7000
In Commercial Distribution

  • 10381780126232 ()
C7000

  • Soft-tissue ultrasonic surgical system
The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy. The Tips deliver the mechanical motion to ablate the tissues then aspirate the waste fluid and suspended tissue pieces. The Flues are hollow cones. The Flues are intended to direct the saline irrigation fluid to the site of operation. They are manufactured from clear plastic.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1529165
Not in Commercial Distribution

  • 30381780122009 ()
  • 10381780122005 ()
  • M26915291651 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® Selector® 24kHz Microsurgical Sterile Tip Set
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1529161
Not in Commercial Distribution

  • 10381780121992 ()
  • M26915291611 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
CUSA® Selector® 24kHz Neuro Long Sterile Tip Set
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523221
Not in Commercial Distribution

  • 10381780121985 ()
  • M26915232211 ()

  • 24kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy. The Tips deliver the mechanical motion to ablate the tissues then aspirate the waste fluid and suspended tissue pieces. The Flues are hollow cones. The Flues are intended to direct the saline irrigation fluid to the site of operation. They are manufactured from clear plastic.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523215
Not in Commercial Distribution

  • 30381780121972 ()
  • 10381780121978 ()
  • M26915232151 ()

  • 24kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use
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