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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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Orthocryl® LC Start-Set international / orthodontic acrylics / For further information please visit our online-shop on our website www.dentaurum.de
DENTAURUM GmbH & Co.KG
160-400-10
Not in Commercial Distribution

  • J011160400100 ()


  • Orthodontic teeth positioner, preformed
Urispec + UA Reader w 4 Promo
HENRY SCHEIN, INC.
5700317
In Commercial Distribution

  • 00304040006580 ()
5700317

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
  • Urine analyser IVD, laboratory, semi-automated
Urispec + UA Reader w 12 Promo
HENRY SCHEIN, INC.
9007507
In Commercial Distribution

  • 00304040001462 ()
9007507

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
  • Urine analyser IVD, laboratory, semi-automated
The CLINITEK Status® Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity andcentralized control of all the satellite Point of Care (POC) Clinitek Status+ analyzers. The connector communicates with remote hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR).
Siemens Healthcare Diagnostics Inc.
10376322
In Commercial Distribution

  • 00630414571263 ()
10376322

  • Multichannel clinical chemistry analyser IVD, laboratory
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
A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current during endotherapy. It consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single use device.
HOBBS MEDICAL, INC.
4577OLY
In Commercial Distribution

  • M8494577OLY0 ()
  • M8494577OLY1 ()
4577OLY

  • Flexible polypectomy snare, single-use
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