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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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CALCANEA - 10381780048435

The CALCANEA variable angle screws are dedicated for the fixation of the CALCANEA Plate. They are made out of Titanium alloy and delivered non sterile. They provide a variable angle for versatile fixation. The range of screws include only one diameter of 3.5mm and a length from 20mm to 45mm (by 5mm). The fixation screws are self tapping, with a smooth tip to protect soft tissues. The screw head design enables a low profile screw/plate/bone interface.
NEWDEAL
180425ND
Not in Commercial Distribution

  • 10381780048435 ()
  • M248180425ND1 ()

  • 3.5mm diam. x 25mm length
180425ND

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

CALCANEA - 10381780048428

The CALCANEA variable angle screws are dedicated for the fixation of the CALCANEA Plate. They are made out of Titanium alloy and delivered non sterile. They provide a variable angle for versatile fixation. The range of screws include only one diameter of 3.5mm and a length from 20mm to 45mm (by 5mm). The fixation screws are self tapping, with a smooth tip to protect soft tissues. The screw head design enables a low profile screw/plate/bone interface.
NEWDEAL
180420ND
Not in Commercial Distribution

  • 10381780048428 ()
  • M248180420ND1 ()

  • 3.5mm diam. x 20mm length
180420ND

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

CALCANEA - 10381780043874

The CALCANEA Plate is a Titanium low profile anatomical plate dedicated for fixation of calcaneal fractures. It enables a reconstruction of height and width of the calcaneus and a possible remodeling to the lateral calcaneus. Its anatomical design provides optimal bone coverage while its low profile provides a minimal irritation of soft tissues. The plate is available in three different sizes for optimal anatomical fit and it is delivered non sterile. Numerous holes enable versatile screw fixation.
NEWDEAL
180030ND
Not in Commercial Distribution

  • M248180030ND1 ()
  • 10381780043874 ()

  • 73mm length x 37mm width
180030ND

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

CALCANEA - 10381780043867

The CALCANEA Plate is a Titanium low profile anatomical plate dedicated for fixation of calcaneal fractures. It enables a reconstruction of height and width of the calcaneus and a possible remodeling to the lateral calcaneus. Its anatomical design provides optimal bone coverage while its low profile provides a minimal irritation of soft tissues. The plate is available in three different sizes for optimal anatomical fit and it is delivered non sterile. Numerous holes enable versatile screw fixation.
NEWDEAL
180020ND
Not in Commercial Distribution

  • M248180020ND1 ()
  • 10381780043867 ()

  • 66mm length x 37mm width
180020ND

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

CALCANEA - 10381780043850

The CALCANEA Plate is a Titanium low profile anatomical plate dedicated for fixation of calcaneal fractures. It enables a reconstruction of height and width of the calcaneus and a possible remodeling to the lateral calcaneus. Its anatomical design provides optimal bone coverage while its low profile provides a minimal irritation of soft tissues. The plate is available in three different sizes for optimal anatomical fit and it is delivered non sterile. Numerous holes enable versatile screw fixation.
NEWDEAL
180010ND
Not in Commercial Distribution

  • M248180010ND1 ()
  • 10381780043850 ()

  • 58mm length x 30mm width
180010ND

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

WIRELESS ECG includes PC based receiver, Trigger out and detachable lead set - 07290110250485

The PCECG 1200W System is comprised of wireless ECG recording box, which is based on an approved hardware, a RF receiver box connected to the computer and an ECG test software application. The intended user (patient) of the device is a subject that is referred to a rest (Stress) test for ischemic heart disease assessment ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value
NORAV MEDICAL LTD.
PCECG 1200W
In Commercial Distribution

  • 07290110250485 ()


  • Electrocardiography telemetric monitoring system transmitter

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

Profile-ESP Radiographic marker - 00868579000278

The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate the conversion of measurement data by the Profile-ESP software to mm units, and facilitates stitching of spinal x-rays as part of the Image Processing service. The marker is placed around the neck of the patient by the medical imaging professional during x-ray imaging. It is shipped by Company personnel to the customer site and includes a user manual in the device package. No additional training or installation is required. Length – approximately 36” / Weight – approximately 5 oz.
ORTHO KINEMATICS, INC.
3.0
In Commercial Distribution

  • 00868579000278 ()


  • Radiographic image marker, manual

MADA MEDICAL PRODUCTS, INC. - 00815160020603

An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a mains electricity (AC-powered) suction pump, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, a moisture filter, and possibly a microbial filter. The pump creates a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of settings within healthcare facilities. 220V.
MADA MEDICAL PRODUCTS, INC
172BS-II220V
In Commercial Distribution

  • 00815160020603 ()
172BS-II220V

  • General-purpose suction system, line-powered
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