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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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Blue Sky Bio, LLC. - 00810060220313

Drill Profiler 3.2mm ID x 4.5mm OD
BLUE SKY BIO LLC
DRILLPR45
In Commercial Distribution

  • 00810060220313 ()


  • Fixture/appliance dental drill bit, reusable

Blue Sky Bio, LLC. - 00810060220306

Drill Profiler 3.2mm ID x 3.7mm OD
BLUE SKY BIO LLC
DRILLPR37
In Commercial Distribution

  • 00810060220306 ()


  • Fixture/appliance dental drill bit, reusable

D3 - 30014613330707

D3 DFA HSV ID AND TYPING KIT
DIAGNOSTIC HYBRIDS, INC.
DFA HSV ID and Typing ID Kit
In Commercial Distribution

  • 30014613330707 ()
01-090000

  • Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, fluorescent immunoassay

D3 Ultra - 30014613330356

D3 Ultra DFA Respiratory Virus ID Set
DIAGNOSTIC HYBRIDS, INC.
01-010007.V2
In Commercial Distribution

  • 30014613330356 ()
01-010007.V2

  • Multiple-genus respiratory virus antigen IVD, kit, fluorescent immunoassay

INSTRUMENT - 07613327252699

RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 68MM ID
Howmedica Osteonics Corp.
5097-6625
In Commercial Distribution

  • 07613327252699 ()

  • Outer Diameter: 66.0 Millimeter
  • Thickness: 25.0 Millimeter
5097-6625

  • Acetabulum prosthesis trial, prefabricated, reusable

INSTRUMENT - 07613327252330

RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 48MM ID
Howmedica Osteonics Corp.
5097-4620
In Commercial Distribution

  • 07613327252330 ()

  • Thickness: 20.0 Millimeter
  • Outer Diameter: 46.0 Millimeter
5097-4620

  • Acetabulum prosthesis trial, prefabricated, reusable

INSTRUMENT - 07613327252316

RESTORATION ACETABULAR WEDGE AUGMENT TRIAL 48MM ID
Howmedica Osteonics Corp.
5097-4615
In Commercial Distribution

  • 07613327252316 ()

  • Thickness: 15.0 Millimeter
  • Outer Diameter: 46.0 Millimeter
5097-4615

  • Acetabulum prosthesis trial, prefabricated, reusable

Standard 64 Sublative iD, (20 Pulse), 10-Pk - 37290109952193

Standard 64 Sublative iD, (20 Pulse), 10-Pk
SYNERON MEDICAL LTD
KT73161
Not in Commercial Distribution

  • 37290109952193 ()
KT73161

  • Multi-modality skin surface treatment system

Focal 90 Sublative iD, (400 Pulse), 10-Pk - 37290109951219

Focal 90 Sublative iD, (400 Pulse), 10-Pk
SYNERON MEDICAL LTD
KT74451
Not in Commercial Distribution

  • 37290109951219 ()
KT74451

  • Multi-modality skin surface treatment system

Focal 44 Sublative iD, (20 Pulse), 10-Pk - 37290109951202

Focal 44 Sublative iD, (20 Pulse), 10-Pk
SYNERON MEDICAL LTD
KT72972
Not in Commercial Distribution

  • 37290109951202 ()
KT72972

  • Multi-modality skin surface treatment system
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