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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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AART Calf Implant - B490502304E0

Calf Sty 3 Sz 4 Sterile
Aart
E
In Commercial Distribution

  • B490502304E0 ()
502-304E

  • Silicone-block tissue reconstructive material

AART Pectoralis Implant Sizer - B49050030262E0

Szr - Pectoral Sty 3 Sz 2 R NS
Aart
E
In Commercial Distribution

  • B49050030262E0 ()
500-302-6-2E

  • Pectoral implant

AART Pectoralis Implant Sizer - B49050030252E0

Szr - Pectoral Sty 3 Sz 2 L NS
Aart
E
In Commercial Distribution

  • B49050030252E0 ()
500-302-5-2E

  • Pectoral implant

AART Pectoralis Implant Sizer - B49050030162E0

Szr - Pectoral Sty 3 Sz 1 R NS
Aart
E
In Commercial Distribution

  • B49050030162E0 ()
500-301-6-2E

  • Pectoral implant

AART Pectoralis Implant Sizer - B49050030152E0

Szr - Pectoral Sty 3 Sz 1 L NS
Aart
E
In Commercial Distribution

  • B49050030152E0 ()
500-301-5-2E

  • Pectoral implant

Stool Bacterial Pathogens Panel - B178GBSBPP100

Stool Bacterial Pathogens Panel Cartridge with sample prep device.
GREAT BASIN SCIENTIFIC, INC.
GBSBPP-10
In Commercial Distribution

  • B178SBPP102 ()
  • B178GBSBPP100 ()
GBSBPP-10

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)

Synergy E - B036101483

Synergy E Host Software for SmartMonitor 2 Product Line
CIRCADIANCE, LLC
101483
In Commercial Distribution

  • B036101483 ()
101483

  • Infant apnoea monitor

E+R - B448FS1030

No Description
Firstar Healthcare Company Limited (Guangzhou)
FS-103
Not in Commercial Distribution

  • B448FS1030 ()


  • Cardiopulmonary resuscitation mask, reusable

BioUniversal E - D7075925370

No Description
IVOCLAR VIVADENT, INC.
592537
Not in Commercial Distribution

  • D7075925370 ()
592537

  • Dental casting noble alloy

BioUniversal E - D7075925320

BioUniversal E 1oz/31 g
IVOCLAR VIVADENT, INC.
592532
Not in Commercial Distribution

  • D7075925320 ()
592532

  • Dental casting noble alloy
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