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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 - 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

CAPTURE™ Screw System - 10381780064527

The Capture Screw System is comprised of Low Profile screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The low profile, cannulated screw is a cannulated, threaded bone screw which is offered in 2.0, 2.5, 3.0, and 4.0mm diameters with lengths of 6 – 50mm. The system includes instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
CAPLOPROIMP
Not in Commercial Distribution

  • M268CAPLOPROIMP1 ()
  • 10381780064527 ()
CAPLOPROIMP

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

CALCANEA - 10381780048473

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
180445ND
Not in Commercial Distribution

  • 10381780048473 ()
  • M248180445ND1 ()

  • 3.5mm diam. x 45mm length
180445ND

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

CALCANEA - 10381780048466

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
180440ND
Not in Commercial Distribution

  • 10381780048466 ()
  • M248180440ND1 ()

  • 3.5mm diam. x 40mm length
180440ND

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

CALCANEA - 10381780048459

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
180435ND
Not in Commercial Distribution

  • 10381780048459 ()
  • M248180435ND1 ()

  • 3.5mm diam. x 35mm length
180435ND

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

CALCANEA - 10381780048442

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
180430ND
Not in Commercial Distribution

  • 10381780048442 ()
  • M248180430ND1 ()

  • 3.5mm diam. x 30mm length
180430ND

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

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

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
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