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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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Permthane X split Long term dual lumen catheter kit size 12 Fr tip to cuff length 15.5 Cm total length 21 Cm
Ameco Medical Industries
PXDLC-1216-K
In Commercial Distribution

  • 06221139059064 ()

  • Length: 16 Centimeter
  • Catheter Gauge: 12 French


  • Double-lumen haemodialysis catheter, implantable
For the quantitative determination of hemoglobin in capillary, venous or arterial whole blood.
STANBIO LABORATORY, L.P.
3025-050
In Commercial Distribution

  • 00657498000236 ()
  • 00657498001455 ()
3025-050

  • Haemoglobin analyser IVD, point-of-care
No Description
HARD MANUFACTURING CO., INC.
1711-BFP
In Commercial Distribution

  • 00852231007552 ()
  • 00852231007545 ()
1711-BFP

  • Paediatric bed
No Description
HARD MANUFACTURING CO., INC.
714-IPGP
In Commercial Distribution

  • 00852231007514 ()
  • 00852231007507 ()
714-IPGP

  • Paediatric bed
100 (5 pouches/bag)
BIOMEDICAL LIFE SYSTEMS, INC.
EDRC225250
Not in Commercial Distribution

  • 00857771003804 ()
EDRC225250

  • Transcutaneous electrical stimulation electrode, single-use
20 per pouch
BIOMEDICAL LIFE SYSTEMS, INC.
EDRC225250
Not in Commercial Distribution

  • 00857771003309 ()
  • 10857771003306 ()
  • 20857771003303 ()
EDRC225250

  • Transcutaneous electrical stimulation electrode, single-use
No Description
Eca Medical Instruments
973-002
In Commercial Distribution

  • 00857676008560 ()
501986

  • Orthopaedic surgical procedure kit, non-medicated, single-use
No Description
Eca Medical Instruments
973-001
In Commercial Distribution

  • 00857676008553 ()
501984

  • Orthopaedic surgical procedure kit, non-medicated, single-use
No Description
AXELGAARD MANUFACTURING CO., LTD.
VTXT50100
In Commercial Distribution

  • 00851913006029 ()


  • Transcutaneous electrical stimulation electrode, single-use
  • Transcutaneous electrical stimulation electrode, reusable
Q-STAIN X Autostainer
NOVODIAX, INC.
IA01-001
In Commercial Distribution

  • 00850036867159 ()
IA01-001

  • Microscope slide maker/stainer IVD
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