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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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Spirotome Bone - 05407005001233

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 08G (5mm) and length of 150 mm.
Bioncise
SS08BO
In Commercial Distribution

  • 05407005000236 ()
  • 05407005001233 ()
SS08BO

  • Soft-tissue biopsy needle, single-use

Jacoti Hearing Center Pro - 05407004250038

Jacoti Hearing Center Pro 1.X
Jacoti
Jacoti Hearing Center Pro 1.X
In Commercial Distribution

  • 05407004250038 ()


  • Tone audiometer, semi-automated

Handi-Move Slide - 05404016612588

Handi Slide padded mini
Handi-Move
3606 00000001
In Commercial Distribution

  • 05404016612588 ()


  • Patient transfer sliding mat

Handi-Move Slide - 05404016612571

Handi Slide padded maxi
Handi-Move
3605 00000001
In Commercial Distribution

  • 05404016612571 ()


  • Patient transfer sliding mat

Sensor Pad - 00850014578145

Sensor Pads are intended for use with Lucerno Dynamics sensors on clean, dry, intact skin. The sensor side adhesive is not intended for skin contact. Factors that may impact pad performance include lotion or other skin products, patient movement, and substantial body hair. Sensor Pads consist of a double-coated, two-in-one medical grade silicone adhesive and acrylic tape. The silicone adhesive is hypoallergenic and atraumatic upon removal; it is intended for attachment to the skin. The acrylic tape is intended for attachment to the plastic case of the sensor.
LUCERNO DYNAMICS, LLC
091220-018
In Commercial Distribution

  • 00850014578145 ()
  • 00850014578138 ()
091220-018

  • Hypoallergenic skin adhesive tape

12mm Distraction Pin-Double - 00850014548070

12mm Distraction Pin-Double
FOLSOM METAL PRODUCTS, INC.
301.912S2
In Commercial Distribution

  • 00850014548070 ()
301.912S2

  • Intraoperative orthopaedic bone pin/screw, single-use

14mm Distraction Pin-Double - 00850014548049

14mm Distraction Pin-Double
FOLSOM METAL PRODUCTS, INC.
301.914S2
In Commercial Distribution

  • 00850014548049 ()
301.914S2

  • Intraoperative orthopaedic bone pin/screw, single-use

14mm Distraction Pin - 00850014548032

14mm Distraction Pin
FOLSOM METAL PRODUCTS, INC.
301.914S1
In Commercial Distribution

  • 00850014548032 ()
301.914S1

  • Intraoperative orthopaedic bone pin/screw, single-use

12mm Distraction Pin - 00850014548001

12mm Distraction Pin
FOLSOM METAL PRODUCTS, INC.
301.912S1
In Commercial Distribution

  • 00850014548001 ()
301.912S1

  • Intraoperative orthopaedic bone pin/screw, single-use

Apex - 05391529580193

Apex Tibia Screw, Sterile
ORTHOXEL DESIGNATED ACTIVITY COMPANY
LS01-50060
In Commercial Distribution

  • 05391529580193 ()

  • 5x60mm


  • Orthopaedic bone screw, non-bioabsorbable, sterile
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