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-004
In Commercial Distribution

  • D767B0105081 ()
  • D767B0104081 ()
B01-0408

  • 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-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
36 Well Test Tray
MEDSCIENCE RESEARCH GROUP, INC.
1001-36
Not in Commercial Distribution

  • B6821001360 ()
1001-36

  • General laboratory assay tray
Bioviva Soluble Dental Hemostatic Gauze
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
BHG
In Commercial Distribution

  • 00817169021964 ()


  • General oral wound dressing, non-animal-derived, sterile
Jamshidi Needle
LINKSPINE, INC.
80-2545
In Commercial Distribution

  • 00817329024576 ()
80-2545

  • Trans-facet-screw internal spinal fixation system, non-sterile
Cannulated Torque Handle
LINKSPINE, INC.
80-2540
In Commercial Distribution

  • 00817329024569 ()
80-2540

  • Trans-facet-screw internal spinal fixation system, non-sterile
Reamer
LINKSPINE, INC.
80-2535
In Commercial Distribution

  • 00817329024552 ()
80-2535

  • Trans-facet-screw internal spinal fixation system, non-sterile
Drill Stop
LINKSPINE, INC.
80-2531
In Commercial Distribution

  • 00817329024545 ()
80-2531

  • Trans-facet-screw internal spinal fixation system, non-sterile
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