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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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Spirotome - 05407005001165

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: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • 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) for use under MR.
Bioncise
SS10MR
In Commercial Distribution

  • 05407005000168 ()
  • 05407005001165 ()
SSA10MR

  • Soft-tissue biopsy needle, single-use

Spirotome - 05407005001158

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: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • 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) for use under MR.
Bioncise
SS08MR
In Commercial Distribution

  • 05407005000151 ()
  • 05407005001158 ()
SS08MR

  • Soft-tissue biopsy needle, single-use

Spirotome - 05407005001141

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: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • 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 60 mm.
Bioncise
SS1406
In Commercial Distribution

  • 05407005000144 ()
  • 05407005001141 ()
SS1406

  • Soft-tissue biopsy needle, single-use

Spirotome - 05407005001134

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: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • 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 80 mm.
Bioncise
SS1408
In Commercial Distribution

  • 05407005000137 ()
  • 05407005001134 ()
SS1408

  • Soft-tissue biopsy needle, single-use

Spirotome - 05407005001127

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: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • 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 100 mm.
Bioncise
SS1410
In Commercial Distribution

  • 05407005000120 ()
  • 05407005001127 ()
SS1410

  • Soft-tissue biopsy needle, single-use

Spirotome - 05407005001110

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: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • 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 150 mm.
Bioncise
SS1415
In Commercial Distribution

  • 05407005000113 ()
  • 05407005001110 ()
SS1415

  • Soft-tissue biopsy needle, single-use

Spirotome - 05407005001103

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: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • 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 60 mm.
Bioncise
SS1006
In Commercial Distribution

  • 05407005000106 ()
  • 05407005001103 ()
SS1006

  • Soft-tissue biopsy needle, single-use

Spirotome - 05407005001097

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: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • 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 80 mm.
Bioncise
SS1008
In Commercial Distribution

  • 05407005000090 ()
  • 05407005001097 ()
SS1008

  • Soft-tissue biopsy needle, single-use

Spirotome - 05407005001080

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: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • 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 100 mm.
Bioncise
SS1010
In Commercial Distribution

  • 05407005000083 ()
  • 05407005001080 ()
SS1010

  • Soft-tissue biopsy needle, single-use

Spirotome - 05407005001073

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: • A two-part introducer needle that consists of a cutting cannula and a trocar stylet • 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 150 mm.
Bioncise
SS1015
In Commercial Distribution

  • 05407005000076 ()
  • 05407005001073 ()
SS1015

  • Soft-tissue biopsy needle, single-use
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