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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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A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient.
JTECH Medical
CT001
In Commercial Distribution

  • G041CT0010 ()


  • Joint/spinal manipulator, mechanical
PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-024
In Commercial Distribution

  • 00618474000152 ()
  • 00618474000145 ()

  • Width: 3.05 Centimeter
  • Length: 2.05 Centimeter


  • Collagen wound matrix dressing
PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-012
In Commercial Distribution


  • Width: 9 Centimeter
  • Length: 6 Centimeter


  • Collagen wound matrix dressing
PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-006
In Commercial Distribution

  • 00618474000060 ()

  • Width: 5 Centimeter
  • Length: 5 Centimeter


  • Collagen wound matrix dressing
PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
515-010
In Commercial Distribution

  • 00618474000053 ()
  • 00618474000138 ()

  • Width: 4 Centimeter
  • Length: 2 Centimeter


  • Collagen wound matrix dressing
PuraPly™ Wound Matrix consists of a single-layer fenestrated sheet of collagen intended for the management of wounds. PuraPly™ Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.
ORGANOGENESIS INC.
1
In Commercial Distribution

  • 00618474000022 ()

  • Area/Surface Area: 54 Square centimeter
  • Area/Surface Area: 8 Square centimeter
  • Area/Surface Area: 25 Square centimeter


  • Collagen wound matrix dressing
HYBENX Advanced Dental Debridement is a topical liquid or gel intended for use as an adjunctive decontamination rinse of tooth surfaces during the performance of certain dental procedures to help remove the smear layer and tooth debris.
Epien Medical, Inc.
109-0004
In Commercial Distribution

  • 00860004740322 ()

  • Total Volume: 1.5 Milliliter
109-0004

  • Dental mouthwash
A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient device.
JTECH Medical
CT012
In Commercial Distribution

  • G041CT0120 ()


  • Joint/spinal manipulator, mechanical
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
A sterile, disposable, single use, wound-dressing device for the management of dermal lesions and injuries. Nuvagen Collagen Powder is a hydrophilic, hydrocolloid wound-powder with a collagen base. It is an insoluble fibrous type I bovine derived from cowhide.
Cpn Biosciences, LLC
2002
In Commercial Distribution

  • 00618474000510 ()
2002

  • Collagen wound matrix dressing
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