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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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Integra® NuGrip® - 10381780237167

The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443L
In Commercial Distribution

  • M269SHP443L1 ()
  • 10381780237167 ()

  • Size Large; .520 in dia
SHP-443-L

  • Bone cutter

GIZA - 07640167930319

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 27 T3 4°
In Commercial Distribution

  • 07640167930319 ()
GL303000S

  • Vertebral body prosthesis

GIZA - 07640167930302

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 27 T2 4°
In Commercial Distribution

  • 07640167930302 ()
GL203000S

  • Vertebral body prosthesis

GIZA - 07640167930296

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 27 T1 4°
In Commercial Distribution

  • 07640167930296 ()
GL103000S

  • Vertebral body prosthesis

GIZA - 07640167930289

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 21 T3 4°
In Commercial Distribution

  • 07640167930289 ()
GT302000S

  • Vertebral body prosthesis

GIZA - 07640167930272

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 21 T2 4°
In Commercial Distribution

  • 07640167930272 ()
GT202000S

  • Vertebral body prosthesis

GIZA - 07640167930265

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy Implant GIZA D 21 T1 4°
In Commercial Distribution

  • 07640167930265 ()
GT102000S

  • Vertebral body prosthesis

GIZA - 07640167930067

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 Deg
In Commercial Distribution

  • 07640167930067 ()
48291437S

  • Vertebral body prosthesis

GIZA - 07640167930050

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 2-5 Deg
In Commercial Distribution

  • 07640167930050 ()
48291432S

  • Vertebral body prosthesis

GIZA - 07640167930043

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 Deg
In Commercial Distribution

  • 07640167930043 ()
48291427S

  • Vertebral body prosthesis

GIZA - 07640167930036

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 Deg
In Commercial Distribution

  • 07640167930036 ()
48291422S

  • Vertebral body prosthesis

GIZA - 07640167930029

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 Deg
In Commercial Distribution

  • 07640167930029 ()
48291485S

  • Vertebral body prosthesis

GIZA - 07640167930012

The GIZA is a spinal vertebral body replacement device.
Eden Spine Europe SA
Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 Deg
In Commercial Distribution

  • 07640167930012 ()
48291482S

  • Vertebral body prosthesis

In-Line Gas Warmer - 00817183020592

In-Line gas warmer is for use with laparoscopic insufflators
NORTHGATE TECHNOLOGIES INC.
72-00204-0
In Commercial Distribution

  • 00817183020592 ()
7209944

  • Insufflation gas conditioning system control unit

In-Line Gas Warmer - 00817183020240

In-Line gas warmer is for use with laparoscopic insufflators
NORTHGATE TECHNOLOGIES INC.
6-810-00
In Commercial Distribution

  • 00817183020240 ()


  • Insufflation gas conditioning system control unit

In-Line Gas Warmer - 00817183020233

In-Line gas warmer is for use with laparoscopic insufflators
NORTHGATE TECHNOLOGIES INC.
6-820-00
In Commercial Distribution

  • 00817183020233 ()


  • Insufflation gas conditioning system control unit

Gas cylinder Restrainer Servo-s - 07325710000588

Following Device Identifier is including in this KIT: 07325710003152
Maquet Critical Care AB
6650514
In Commercial Distribution

  • 07325710000588 ()


  • Neonatal/adult intensive-care ventilator

Tobii Dynavox - 07340074600328

Speech Generating Device with Eyegaze (IS 4) 12" Screen
TOBII DYNAVOX LLC
I-12+ IS4
Not in Commercial Distribution

  • 07340074600328 ()


  • Voice synthesizer/digitizer

Tobii Dynavox - 07340074600274

Speech Generating Device with Eyegaze (IS 20) 15" Screen
TOBII DYNAVOX LLC
I-15+ IS20
Not in Commercial Distribution

  • 07340074600274 ()


  • Voice synthesizer/digitizer

Non-woven 4"x4" 4-ply - 00850014433444

is a sponge for wound dressing, prepping, and scrubbing.
DISTRIBUTION UNLIMITED, LLC
1
In Commercial Distribution

  • 10850014433441 ()
  • 00850014433444 ()
  • 20850014433448 ()

  • Height: 4 Inch
  • Length: 4 Inch
DU1204

  • Non-woven gauze pad, non-sterile
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