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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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Malibu - 10889981028121

Malibu Deformity Hook Implant. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt.
Seaspine Orthopedics Corporation
MLBDHIMP
In Commercial Distribution

  • 10889981028121 ()
MLBDHIMP

  • Vertebral body prosthesis, non-sterile

Zeramex XT Surgery Tray - 07640161391765

Tools
CeramTec Schweiz GmbH
XT48850
In Commercial Distribution

  • 07640161391765 ()
XT48850

  • Dental implant/prosthesis surgical procedure kit

Spirotome Endo - 05407005001219

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

Spirotome Endo - 05407005001202

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

Spirotome Endo - 05407005001196

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

Spirotome Cervicore - 05407005001189

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

Spirotome Cervicore - 05407005001172

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

VISIONIX - 03664188000909

The VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil Image Image of the cornea relative to the iris
LUNEAU TECHNOLOGY OPERATIONS
VX130
In Commercial Distribution

  • 03664188000909 ()


  • Automated ophthalmic refractometer
  • Optical pachymeter
  • Ophthalmic tonometer, battery-operated

Cellfina System Cart - 00840763101015

No Description
Ulthera, Inc.
Rev R
In Commercial Distribution

  • 00840763101015 ()
1010103

  • Operating table accessory trolley

VISIONIX - 03664188000039

The VX130+ is a multifunctional eye diagnostic device. There are several operation modes combined in a single platform: aberrometer, autorefractometer, keratometer, corneal topographer, tonometer, multi-slit pachymeter, tear-film analyzer , and retro illumination. The VX130+ is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measuring the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea. Full cornea thickness map Scheimpflug imaging Anterior chamber imaging Pupil Image Image of the cornea relative to the iris Analysis of the tear film and evaluation of tear film non-invasive tear break-up time (NITBUT) Meibomian glands imaging Evaluation of tear meniscus height
LUNEAU TECHNOLOGY OPERATIONS
VX130+
In Commercial Distribution

  • 03664188000039 ()


  • Automated ophthalmic refractometer
  • Optical pachymeter
  • Ophthalmic tonometer, battery-operated
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