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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 device intended to flush endoscopes.
Wassenburg Medical, Inc.
83-S6
Not in Commercial Distribution

  • PPS83S6 ()


  • Endoscope washer/disinfector
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-005
In Commercial Distribution

  • D767B0105101 ()
  • D767B010501 ()
B01-0510

  • 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-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
StimQ Freedom-8A Receiver Kit Channel A US w/ Receiver StimQ Peripheral Nerve Stimulator System
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-RCV-A0
In Commercial Distribution

  • 00818225020815 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system
StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Receiver Kit Channel B US w/ Receiver
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-RCV-B0
In Commercial Distribution

  • 00818225020808 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system
StimQ Peripheral Nerve Stimulator System StimQ Freedom-8A Trial Kit Channel A US w/ Receiver
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-TRL-A0
In Commercial Distribution

  • 00818225020792 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system
StimQ Peripheral Nerve Stimulator System
STIMWAVE TECHNOLOGIES INCORPORATED
FR8A-TRL-B0
In Commercial Distribution

  • 00818225020785 ()

  • Weight: 0.25 Gram
  • Length: 45 Centimeter
  • Outer Diameter: 1.35 Millimeter


  • Analgesic implantable peripheral nerve electrical stimulation system
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