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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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BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.
UNICARE BIOMEDICAL INC.
C-003
In Commercial Distribution

  • D767B0103081 ()
  • D767B010301 ()
B01-0308

  • General oral wound dressing, non-animal-derived, sterile
BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.
UNICARE BIOMEDICAL INC.
C-002
In Commercial Distribution

  • D767B0102121 ()
  • D767B010201 ()
B01-0212

  • General oral wound dressing, non-animal-derived, sterile
BenaCel® dental dressing is made of biocompatible oxidized cellulose and contains no chemical additives. BenaCel® dental dressing adheres to moist oral mucosa and forms a temporary barrier protecting the wound from further irritation and pain. When placed in the extraction socket, BenaCel® dental dressing forms a gelatinous scaffold in the blood extrude, facilitating the development of a stable blood clot to prevent dry socket formation. BenaCel® dental dressing is designed for use in the extraction site and the management of bleeding and alveolar osteitis (dry socket). It may also be used as a wound dressing for the temporary management of oral surgical wounds, such as operative, postoperative, donor sites and traumatic injuries.
UNICARE BIOMEDICAL INC.
C-001
In Commercial Distribution

  • D767B0101081 ()
  • D767B010101 ()
B01-0108

  • General oral wound dressing, non-animal-derived, sterile
Absorbable Dental Wound Dressing
Osteogenics Biomedical Inc
RTMTAPE10
In Commercial Distribution

  • D765RTMTAPE100 ()
  • D765RTMTAPE101 ()

  • Width: 2.5 Centimeter
  • Length: 7.5 Centimeter


  • General oral wound dressing, animal-derived
Absorbable Dental Wound Dressing
Osteogenics Biomedical Inc
RTMPLUG10
In Commercial Distribution

  • D765RTMPLUG100 ()
  • D765RTMPLUG101 ()

  • Width: 1 Centimeter
  • Length: 2 Centimeter


  • General oral wound dressing, animal-derived
Absorbable Dental Wound Dressing
Osteogenics Biomedical Inc
RTMFOAM10
In Commercial Distribution

  • D765RTMFOAM100 ()
  • D765RTMFOAM101 ()

  • Width: 2 Centimeter
  • Length: 4 Centimeter


  • General oral wound dressing, animal-derived
No Description
ICP, INC.
51-9597150
In Commercial Distribution

  • D7715195971500 ()
  • D7715195971501 ()


  • Dental appliance fabrication material, thermoplastic
No Description
ICP, INC.
51-9597090
In Commercial Distribution

  • D7715195970900 ()
  • D7715195970901 ()


  • Dental appliance fabrication material, thermoplastic
No Description
ICP, INC.
51-9596980
In Commercial Distribution

  • D7715195969800 ()
  • D7715195969801 ()


  • Dental appliance fabrication material, thermoplastic
The Compartmental Compressibility Monitoring System (CPMX1) is a point-of-care device for non-invasive, real-time, and intermittent monitoring of relative compartment compressibility. The CPMX1 System includes the CP Probe, a handheld and reusable probe combining a flat linear ultrasound array with an integrated pressure sensor to obtain cross-section ultrasound views of the compartment of interest. The CP Probe works in conjunction with the CPMX1 Software, which provides a surrogate metric of the compartment's compressibility in one ultrasound image plane only, using a linear measurement of distance between two points of the compartment, as a function of applied external pressure. Based on this measurement, a relative compartment compressibility value is calculated and displayed on-screen as the CP Value.
Compremium AG
1
In Commercial Distribution

  • G247CPMX10 ()
  • G247CPMX12 ()


  • Compartmental-pressure monitoring system, reusable
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