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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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Treatment table
Lojer Oy
Capre FX3
In Commercial Distribution

  • 06430021930569 ()
Capre FX3

  • Examination/treatment table, line-powered
Treatment table
Lojer Oy
Capre F5
In Commercial Distribution

  • 06430021930521 ()
Capre F5

  • Examination/treatment table, line-powered
Treatment table
Lojer Oy
Capre M4 AM
In Commercial Distribution

  • 06430021930477 ()
Capre M4 AM

  • Examination/treatment table, line-powered
The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine.
BM KOREA CO., LTD
2BMK(T)15αS
In Commercial Distribution

  • 08809255540987 ()

  • Length: 15 Millimeter


  • Catheter/overtube balloon inflator, single-use
The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine.
BM KOREA CO., LTD
BMK(T)15αS
In Commercial Distribution

  • 08809255544633 ()
  • 08809255542639 ()


  • Catheter/overtube balloon inflator, single-use
No Description
MANUKAMED LIMITED PARTNERSHIP
MM0032
Not in Commercial Distribution

  • 05060188820147 ()
  • 05060188820130 ()


  • Exudate-absorbent dressing, non-gel, antimicrobial
No Description
Drägerwerk AG & Co. KGaA
8418458
In Commercial Distribution

  • 04048675028642 ()


  • Ventilator breathing circuit, reusable
No Description
Drägerwerk AG & Co. KGaA
8409634
In Commercial Distribution

  • 04048675028512 ()


  • Ventilator breathing circuit, reusable
No Description
Drägerwerk AG & Co. KGaA
8402041
In Commercial Distribution

  • 04048675026488 ()


  • Ventilator breathing circuit, reusable
No Description
Drägerwerk AG & Co. KGaA
2165600
Not in Commercial Distribution

  • 04048675023425 ()


  • Ventilator breathing circuit, reusable
No Description
Drägerwerk AG & Co. KGaA
2165848
In Commercial Distribution

  • 04048675014270 ()


  • Ventilator breathing circuit, reusable
No Description
Drägerwerk AG & Co. KGaA
8410709
In Commercial Distribution

  • 04048675010470 ()


  • Ventilator breathing circuit, reusable
mrdh Bandage 10 cm x 10 cm (4" x 4")
Marine Polymer Technologies, Inc.
400-14
In Commercial Distribution

  • 10389142000114 ()
  • 00389142000117 ()


  • Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
No Description
SCIMEDX CORPORATION
I-EBV01X
In Commercial Distribution

  • 00813545025564 ()
I-EBV01X

  • Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
MODEL 5004, 110V
ORMCO CORPORATION
973-0212
In Commercial Distribution

  • 00889989069532 ()


  • Endodontic filling material condenser
Heat Source, Model 1005
ORMCO CORPORATION
952-0001
In Commercial Distribution

  • 00889989068412 ()


  • Endodontic filling material condenser
VITALITY SCANNER 2006
ORMCO CORPORATION
973-0234
Not in Commercial Distribution

  • 00889989069709 ()


  • Dental pulp analysis system
ELEMENTS DIAGNOSTIC UNIT W/O SATELLITE
ORMCO CORPORATION
973-0320
In Commercial Distribution

  • 00889989061888 ()


  • Dental pulp analysis system
ELEMENTS DIAGNOSTIC UNIT
ORMCO CORPORATION
973-0300
In Commercial Distribution

  • 00889989061871 ()


  • Dental pulp analysis system
S/ETCH JUMBO 2X25ML SYR
SDI LIMITED
8100059
In Commercial Distribution

  • 09336472012052 ()
8100059

  • Dental etching solution
S/ETCH 12GM SYR WITH TIPS
SDI LIMITED
8100052
In Commercial Distribution

  • 09336472012007 ()
8100052

  • Dental etching solution
S/ETCH 10X2ML SYR KT
SDI LIMITED
8100045
In Commercial Distribution

  • 09336472011963 ()
8100045

  • Dental etching solution
S/ETCH 3X2ML SYR KT
SDI LIMITED
8100040
In Commercial Distribution

  • 09336472011932 ()
8100040

  • Dental etching solution
Growth Hormone 2 Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
511ro
In Commercial Distribution

  • 00850011135808 ()


  • Insulin-like growth factor binding protein 3 (IGFBP-3) IVD, control
AccuTrak Abeta42 Calibration Verification Panel
Lgc Clinical Diagnostics, Inc.
2400-0258
In Commercial Distribution

  • 00850011135792 ()


  • Amyloid B component IVD, control
VALIDATE tTau CSF Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
805re
In Commercial Distribution

  • 00850011135785 ()


  • Tau protein IVD, control
VALIDATE pTau181 CSF Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
804re
In Commercial Distribution

  • 00850011135778 ()


  • Tau protein IVD, control
VALIDATE MTX Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
310ro
In Commercial Distribution

  • 00850011135761 ()


  • Methotrexate therapeutic drug monitoring IVD, control
VALIDATE pTau181 Plasma Calibration Verification / Linearity Test Kit
Lgc Clinical Diagnostics, Inc.
806re
In Commercial Distribution

  • 00850011135754 ()


  • Tau protein IVD, control
Validate LCMS VIT D Test Kit
Lgc Clinical Diagnostics, Inc.
1001ro
In Commercial Distribution

  • 00850011135730 ()


  • Multiple form 25-hydroxy Vitamin D IVD, control
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