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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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Post-Operative Care Kit with 10/55 Tube & EasyFlow HME
Freudenberg Medical, LLC
PK 2103
In Commercial Distribution

  • 00848253003429 ()


  • Tracheostomy tube neck holder, reusable
  • Laryngectomy tube, non-sterile
  • Heat/moisture exchanger, single-use
  • Removable ambulatory appliance skin-adherent patch
  • Tracheostomy base plate, reusable
  • Tracheostoma shower shield
Post-Operative Care Kit with 9/55 Tube & EasyFlow HME
Freudenberg Medical, LLC
PK 2102
In Commercial Distribution

  • 00848253003412 ()


  • Tracheostoma shower shield
  • Tracheostomy base plate, reusable
  • Removable ambulatory appliance skin-adherent patch
  • Heat/moisture exchanger, single-use
  • Laryngectomy tube, non-sterile
  • Tracheostomy tube neck holder, reusable
Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME
Freudenberg Medical, LLC
PK 2101
In Commercial Distribution

  • 00848253003405 ()


  • Tracheostomy tube neck holder, reusable
  • Laryngectomy tube, non-sterile
  • Heat/moisture exchanger, single-use
  • Removable ambulatory appliance skin-adherent patch
  • Tracheostomy base plate, reusable
  • Tracheostoma shower shield
Post-Operative Care Kit with 9/55 Tube & ClassicFlow HME
Freudenberg Medical, LLC
PK 2100
In Commercial Distribution

  • 00848253003399 ()


  • Tracheostoma shower shield
  • Tracheostomy base plate, reusable
  • Removable ambulatory appliance skin-adherent patch
  • Heat/moisture exchanger, single-use
  • Laryngectomy tube, non-sterile
  • Tracheostomy tube neck holder, reusable
Post-Operative Care Kit with 12/55 Tube & ClassicFlow HME
Freudenberg Medical, LLC
PK 2106
In Commercial Distribution

  • 00848253003634 ()


  • Tracheostomy tube neck holder, reusable
  • Laryngectomy tube, non-sterile
  • Heat/moisture exchanger, single-use
  • Removable ambulatory appliance skin-adherent patch
  • Tracheostomy base plate, reusable
  • Tracheostoma shower shield
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • An introducer needle that consists of a cutting cannula • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 14G (2.5 mm) and length of 350 mm.
Bioncise
SS14EN
In Commercial Distribution

  • 05407005000212 ()
  • 05407005001219 ()
SS14EN

  • Soft-tissue biopsy needle, single-use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • An introducer needle that consists of a cutting cannula • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 10G (4mm) and length of 350 mm.
Bioncise
SS10EN
In Commercial Distribution

  • 05407005000205 ()
  • 05407005001202 ()
SS10EN

  • Soft-tissue biopsy needle, single-use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • An introducer needle that consists of a cutting cannula • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 08G (5mm) and length of 350 mm.
Bioncise
SS08EN
In Commercial Distribution

  • 05407005000199 ()
  • 05407005001196 ()
SS08EN

  • Soft-tissue biopsy needle, single-use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • An introducer needle that consists of a cutting cannula • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 8G (5 mm) and length of 200 mm.
Bioncise
SS08CE
In Commercial Distribution

  • 05407005000182 ()
  • 05407005001189 ()
SS08CC

  • Soft-tissue biopsy needle, single-use
The Spirotome Biopsy Needle Set is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles, and liver. The Spirotome Biopsy Needle Set contains: • An introducer needle that consists of a cutting cannula • A helical-tip receiving needle that has been sized to fit through the lumen of the cutting cannula • A release element This presentation has an external diameter of 10G (4 mm) and length of 200 mm.
Bioncise
SS10CE
In Commercial Distribution

  • 05407005000175 ()
  • 05407005001172 ()
SS10CE

  • Soft-tissue biopsy needle, single-use
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