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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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DD Bio Splint P HI - EDDIK401301

DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months.
Dental Direkt GmbH
98H30
In Commercial Distribution

  • EDDIK401301 ()

  • Height: 30 Millimeter
  • Outer Diameter: 98.5 Millimeter
K40130

  • Dental appliance fabrication material, thermoplastic

DD Bio Splint P HI - EDDIK401251

DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months.
Dental Direkt GmbH
98H25
In Commercial Distribution

  • EDDIK401251 ()

  • Height: 25 Millimeter
  • Outer Diameter: 98.5 Millimeter
K40125

  • Dental appliance fabrication material, thermoplastic

DD Bio Splint P HI - EDDIK401201

DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months.
Dental Direkt GmbH
98H20
In Commercial Distribution

  • EDDIK401201 ()

  • Height: 20 Millimeter
  • Outer Diameter: 98.5 Millimeter
K40120

  • Dental appliance fabrication material, thermoplastic

DD Bio Splint P HI - EDDIK401151

DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems. DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite regulators for long-term application in the oral cavity up to 12 months.
Dental Direkt GmbH
98H15
In Commercial Distribution

  • EDDIK401151 ()

  • Height: 15 Millimeter
  • Outer Diameter: 98.5 Millimeter
K40115

  • Dental appliance fabrication material, thermoplastic

Khan Kinetic Treatment Device (KKT-M2) - B854M20

The KKT-M2 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.
Optima Health Solutions International Corporation
KKT-M2
In Commercial Distribution

  • B854M20 ()
M2

  • Physical therapy ultrasound system

RADGIL2 - B850033600040

x rays blood irradiator
GILARDONI SPA
RADGIL2 US
In Commercial Distribution

  • B850033600040 ()
03360004

  • In vitro ionizing-radiation blood irradiator

Toe MotionTM - M5289P15S180A0

Fixation Component, DF-P
ARTHROSURFACE INCORPORATED
9P15-S180-A
In Commercial Distribution

  • M5289P15S180A0 ()

  • Outer Diameter: 13.6 Millimeter
9P15-S180-A

  • Total metatarsophalangeal joint prosthesis, modular

Toe MotionTM - M5289P15PB02A0

Modular Insert, 2.5mm Offset -02 (4.6mm thick)
ARTHROSURFACE INCORPORATED
9P15-PB02-A
In Commercial Distribution

  • M5289P15PB02A0 ()
9P15-PB02-A

  • Total metatarsophalangeal joint prosthesis, modular

Toe MotionTM - M5289P15PB01A0

Modular Insert, 2.5mm Offset -01 (3.6mm thick)
ARTHROSURFACE INCORPORATED
9P15-PB01-A
In Commercial Distribution

  • M5289P15PB01A0 ()
9P15-PB01-A

  • Total metatarsophalangeal joint prosthesis, modular

Toe MotionTM - M5289P15PA02A0

Modular Insert, 1.5mm Offset -02 (4.6mm thick)
ARTHROSURFACE INCORPORATED
9P15-PA02-A
In Commercial Distribution

  • M5289P15PA02A0 ()
9P15-PA02-A

  • Total metatarsophalangeal joint prosthesis, modular
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