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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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BIOSTEP LP - 00713980023326

BioStep LP, Size 28, Left, Rate G, Dark
Alps South, LLC
BSLP-28LG-D
In Commercial Distribution

  • 00713980023326 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980022527

BioStep LP, Size 25, Right, Rate G, Dark
Alps South, LLC
BSLP-25RG-D
In Commercial Distribution

  • 00713980022527 ()


  • Mechanical-resistance external ankle-foot prosthesis

BIOSTEP LP - 00713980022367

BioStep LP, Size 25, Left, Rate G, Dark
Alps South, LLC
BSLP-25LG-D
In Commercial Distribution

  • 00713980022367 ()


  • Mechanical-resistance external ankle-foot prosthesis

HEPRO.US Syringe 20ml/cc 18 G x 1 - 00854427007810

HEPRO.US Syringe 20ml/cc 18 G x 1
HEPRO.US INC.
SINGLE - 20ml/cc 18Gx1
In Commercial Distribution

  • 00854427007810 ()


  • General-purpose syringe, single-use

IPS Empress - DIVO5794161

IPS Empress E.V. Mod. 1 g basic red
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
579416
Not in Commercial Distribution

  • DIVO5794161 ()
  • DIVO5794162 ()
579416

  • Dental appliance fabrication material, ceramic

IPS Empress Esthetic - DIVO5794141

IPS Empress E.V. Mod. 1 g sky blue
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
579414
Not in Commercial Distribution

  • DIVO5794141 ()
  • DIVO5794142 ()
579414

  • Dental appliance fabrication material, ceramic

IPS Empress Esthetic - DIVO5793881

IPS Empress E.V. Incisal Opal 20 g LT
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
579388
Not in Commercial Distribution

  • DIVO5793881 ()
579388

  • Dental appliance fabrication material, ceramic

Lumipulse G pTau 217 Plasma Calibrators - 05414470815579

Lumipulse G pTau 217 Plasma Calibrators 1x5C, IVD-US
Fujirebio Europe
81557
In Commercial Distribution

  • 05414470815579 ()

  • 5 bottles per unit; 1.5 mL per bottle


  • Tau protein IVD, calibrator

IPS Empress Esthetic - DIVO5640801

IPS Empress Add-On 770°C1418°F 20 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
564080
Not in Commercial Distribution

  • DIVO5640801 ()
564080

  • Dental appliance fabrication material, ceramic

IPS e.max Ceram - DIVO5970451

IPS e.max Ceram Glaze Powder FLUO 5 g
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
597045
In Commercial Distribution

  • DIVO5970451 ()
597045

  • Dental appliance fabrication material, ceramic
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