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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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Vitegra® - 04250337119852

Vitegra® pro with footswitch
Joimax GmbH
ICS1710FS
In Commercial Distribution

  • 04250337119852 ()

  • visual integration image capture system
ICS1710FS

  • Medical image management system

palm-handle - 04250337112877

Multifunctional Palm Handle with Quick-Lock
Joimax GmbH
TECH12121
In Commercial Distribution

  • 04250337112877 ()

  • L 107.5 mm / OD 20.0 mm
TECH12121

  • Surgical instrument handle, non-torque-limiting

Hammer - 04250337108368

Metal Hammer with Silicone Handle
Joimax GmbH
JMPS50023
In Commercial Distribution

  • 04250337108368 ()

  • 500 g / L 226 mm
JMPS50023

  • Surgical mallet

Chisel - 04250337101772

Working Tube, Chisel with Plate
Joimax GmbH
WTC225564P
In Commercial Distribution

  • 04250337101772 ()

  • L 221 mm / ID 5.5 mm / OD 6.4 mm
WTC225564P

  • Endoscope sheath, reusable

ACIF Interbody System Instruments - M6950CR0001210

Cervical Inserter with Impaction Cap
Tyber Medical LLC
0CR-000121
In Commercial Distribution

  • M6950CR0001210 ()
0CR-000121

  • Metal-polymer composite spinal interbody fusion cage

Blizzard Casualty Blanket XL + Heat pads - M689BH01020

Blizzard Blanket with Heat Pads
Safeguard US Operating, LLC
2
In Commercial Distribution

  • M689BH01020 ()
BH-01

  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use

Blizzard Casualty Blanket XL + Heat pads - M689BH01010

Blizzard Blanket with Heat Pads
Safeguard US Operating, LLC
1
In Commercial Distribution

  • M689BH01010 ()
BH-01

  • Bed blanket, single-use
  • Hot/cold therapy pack, single-use

EMA Now - 00842326101166

Full kit with all components
The Myerson Company Limited
EMANOW21
In Commercial Distribution

  • 00842326101166 ()


  • Mandible-repositioning sleep-disordered breathing orthosis

EMA - 00842326100541

EMA Kit4 with 120mmx2.5mm disc
The Myerson Company Limited
EMAKT12010
In Commercial Distribution

  • 00842326100541 ()

  • Height: 2.5 Millimeter
  • Outer Diameter: 120 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis

EMA - 00842326100534

EMA Kit3 with 120mmx2.0mm disc
The Myerson Company Limited
EMAKT12008
In Commercial Distribution

  • 00842326100534 ()

  • Height: 2.0 Millimeter
  • Outer Diameter: 120 Millimeter


  • Mandible-repositioning sleep-disordered breathing orthosis
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