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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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Coala Heart Monitor US Rx - 07350002700105

The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician.
Coala-Life AB
201
In Commercial Distribution

  • 27350002700123 ()
  • 07350002700105 ()
  • 17350002700119 ()
N/A

  • Phonocardiograph
  • Electrocardiograph, home-use

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

Vu a-POD™ - 10889981038106

27x21mm Trial 12mm 12 deg. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage.
Seaspine Orthopedics Corporation
21-21-2712
In Commercial Distribution

  • 10889981038106 ()

  • 27x21mm 12mm 12°
21-21-2712

  • Bone-screw internal spinal fixation system, non-sterile

Vu a-POD™ - 10889981038090

27x21mm Trial 10mm 12 deg. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage.
Seaspine Orthopedics Corporation
21-21-2710
In Commercial Distribution

  • 10889981038090 ()

  • 27x21mm 10mm 12°
21-21-2710

  • Bone-screw internal spinal fixation system, non-sterile

Vu a-POD™ - 10889981037857

39x30 12mm Spin Plate. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage.
Seaspine Orthopedics Corporation
21-11-3912
In Commercial Distribution

  • 10889981037857 ()

  • 39x30 12mm
21-11-3912

  • Bone-screw internal spinal fixation system, non-sterile

Vu a-POD™ - 10889981037826

35x27 16mm Spin Plate. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage.
Seaspine Orthopedics Corporation
21-11-3516
In Commercial Distribution

  • 10889981037826 ()

  • 35x27 16mm
21-11-3516

  • Bone-screw internal spinal fixation system, non-sterile

Vu a-POD™ - 10889981037802

35x27 12mm Spin Plate. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage.
Seaspine Orthopedics Corporation
21-11-3512
In Commercial Distribution

  • 10889981037802 ()

  • 35x27 12mm
21-11-3512

  • Bone-screw internal spinal fixation system, non-sterile

Vu a-POD™ - 10889981037796

35x27 10mm Spin Plate. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage.
Seaspine Orthopedics Corporation
21-11-3510
In Commercial Distribution

  • 10889981037796 ()

  • 35x27 10mm
21-11-3510

  • Bone-screw internal spinal fixation system, non-sterile

Vu a-POD™ - 10889981037727

27x21 12mm Spin Plate. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage.
Seaspine Orthopedics Corporation
21-11-2712
In Commercial Distribution

  • 10889981037727 ()

  • 27x21 12mm
21-11-2712

  • Bone-screw internal spinal fixation system, non-sterile

Vu a-POD™ - 10889981037710

27x21 10mm Spin Plate. The Vu a-POD intervertebral body fusion device is comprised of polymer (PEEK OPTIMA® LT) concave cages. The PEEK cages include tantalumpins (or radiopaque markers) for radiological evaluation. All pins are press fit into the PEEK material. The pins are placed in the implant on each end of the PEEK cages to allow easier radiological assessment of the position and orientation of the radiolucent PEEK cage.
Seaspine Orthopedics Corporation
21-11-2710
In Commercial Distribution

  • 10889981037710 ()

  • 27x21 10mm
21-11-2710

  • Bone-screw internal spinal fixation system, non-sterile
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