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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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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 - 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

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

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

810nm 200mW Acu Tip PRX100 B/G - 05060494130398

S2093 810nm 200mW Acu Tip PRX100 B/G
THOR PHOTOMEDICINE LIMITED
2.3
In Commercial Distribution

  • 05060494130398 ()


  • Red-light phototherapy unit, professional

Medline Industries, Inc. - 10889942179602

EXTENSIVE D AND C PK,STRL F G
MEDLINE INDUSTRIES, INC.
DYNJ45648A
In Commercial Distribution

  • 10889942179602 ()
DYNJ45648A

  • General surgical procedure kit, non-medicated, single-use

Tilcare - 05060665920506

29 G 12.7 mm insulin syringe 1 ML
TILCO TRADING PTE. LTD.
29 G 12.7 mm insulin syringe 1 ml
In Commercial Distribution

  • 15060665920503 ()
  • 05060665920506 ()
  • 25060665920500 ()

  • Total Volume: 1 Milliliter


  • Medication transfer set

Tilcare - 05060665920490

31 G 8 mm insulin syringe 1 ml
TILCO TRADING PTE. LTD.
31 G 8 mm insulin syringe
In Commercial Distribution

  • 15060665920497 ()
  • 05060665920490 ()
  • 25060665920494 ()

  • Total Volume: 1 Milliliter


  • Medication transfer set
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