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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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Inion instrument - M224INS91039

2.5 mm bone tap with 10 mm stop
Inion Oy
0
In Commercial Distribution

  • M224INS91039 ()
INS-9103

  • Bone tap, reusable

Inion instrument - M224INS90989

2.0 mm bone tap (AO-bayonet)
Inion Oy
0
In Commercial Distribution

  • M224INS90989 ()
INS-9098

  • Bone tap, reusable

Inion instrument - M224INS90979

2.0 mm self tapping drill bit (AO-bayonet)
Inion Oy
0
Not in Commercial Distribution

  • M224INS90979 ()
INS-9097

  • Fluted surgical drill bit, reusable

Inion instrument - M224INS90959

Screwdriver shaft, hexalobular, cannulated
Inion Oy
0
In Commercial Distribution

  • M224INS90959 ()
INS-9095

  • Surgical screwdriver, reusable

Inion instrument - M224INS90949

Screwdriver shaft, crosshead
Inion Oy
0
In Commercial Distribution

  • M224INS90949 ()
INS-9094

  • Surgical screwdriver, reusable

Inion instrument - M224INS90849

4.5 mm cortex screw bone tap, cannulated
Inion Oy
0
In Commercial Distribution

  • M224INS90849 ()
INS-9084

  • Bone tap, reusable

Inion instrument - M224INS90629

2.8 mm bone tap with 42 mm stop (manual)
Inion Oy
0
Not in Commercial Distribution

  • M224INS90629 ()
INS-9062

  • Bone tap, reusable

Inion instrument - M224INS90619

2.5 mm bone tap with 32 mm stop
Inion Oy
0
Not in Commercial Distribution

  • M224INS90619 ()
INS-9061

  • Bone tap, reusable

Inion instrument - M224INS90609

2.0 mm bone tap with 22 mm stop
Inion Oy
0
In Commercial Distribution

  • M224INS90609 ()
INS-9060

  • Bone tap, reusable

Inion instrument - M224INS90599

1.5 mm bone tap with 16 mm stop
Inion Oy
0
In Commercial Distribution

  • M224INS90599 ()
INS-9059

  • Bone tap, reusable

Inion GTR instrument - M224INS90529

Re-usable tack applicator
Inion Oy
0
In Commercial Distribution

  • M224INS90529 ()
INS-9052

  • Bone tack inserter, basic

Epicel (cultured epidermal autografts) - W41020AU201P0001

Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft

Self-Adhesive Electrode 2" x 4" Pro Pulse HD - B243PSSA2X4PP4

Self-Adhesive Electrode
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSSA2X4PP4 ()


  • Transdermal medication patch

Self-Adhesive Electrode 2" x 2" Pro Pulse HD - B243PSSA2X2PP4

Self-Adhesive Electrode
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSSA2X2PP4 ()


  • Transcutaneous electrical stimulation electrode, single-use

Carbon-Rubber Electrodes (2" Round) - B243PSRCR552

No Description
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
In Commercial Distribution

  • B243PSRCR552 ()


  • Transcutaneous electrical stimulation electrode, single-use

Carbon-Rubber Electrodes (8" x 3") - B243PSRCR2102

No Description
ELECTRO MEDICAL TECHNOLOGIES, LLC
0
Not in Commercial Distribution

  • B243PSRCR2102 ()


  • Transcutaneous electrical stimulation electrode, single-use

Lever Action Plate System - B666MCGK60620

K-WIRE .062 (1.6MM) X 6" LG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGK60620 ()
MCGK6-062

  • Orthopaedic bone pin, non-bioabsorbable

Lever Action Plate System - B666MCGK40620

K-WIRE .062 (1.6MM) X 4" LG
MCGINLEY ORTHOPAEDIC INNOVATIONS, LLC
0
In Commercial Distribution

  • B666MCGK40620 ()
MCGK4-062

  • Orthopaedic bone pin, non-bioabsorbable

3T 16ch Flex SPEEDER Large - 00856181003244

The NeoCoil 3T l6ch Flex SPEEDER Coils are a receive-only phased array coil system designed to provide high resolution imaging for the upper and lower extremities, chest, abdomen, pelvis. head, neck, and spine. The system is compatible with 20, 3D, parallel and isotropic imaging, as well as, coil signal intensity correction.
NEOCOIL, LLC
24
In Commercial Distribution

  • 00856181003244 ()


  • MRI system coil, radio-frequency

stratosphere - 04262384030004

Massager for body sculpting and anti-cellulite procedures.
Saxony Beauty Technology GmbH
24
In Commercial Distribution

  • 04262384030004 ()

  • Length: 50 Centimeter
  • Width: 41 Centimeter
  • Height: 101 Centimeter
TMSTR01

  • Hand-held electric massager
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