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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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One device is included 100 test strips
DFI CO.,LTD
30D4
Not in Commercial Distribution

  • 08806141303497 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
The Multiple Name for PORT-XII is ZEN-PX2.
GENORAY CO., LTD.
PORT-XII
In Commercial Distribution

  • 08809244061035 ()


  • Portable basic diagnostic x-ray system, digital
Camera is intended for surgical/operative procedures.
UNIVLABS TECHNOLOGIES PRIVATE LIMITED
UL3Chip-4K
Not in Commercial Distribution

  • 08908025548083 ()


  • Endoscopic video image processing unit
SCHUKNECHT FOREIGN BODY REMOVER INSTRUMENT IS AUTOCLAVABLE
Gyrus ACMI, LLC
130800
In Commercial Distribution

  • 00821925016835 ()


  • Surgical irrigation/aspiration handpiece, single-use
Power Cord, Med4 Elite, IS 6538 India
Avanos Medical, Inc.
303839
In Commercial Distribution

  • 00812120002532 ()


  • Circulating-fluid localized thermal/compression therapy system control unit
Speech Generating Device with Eyegaze (IS 20)
TOBII DYNAVOX LLC
I-12+ IS20
Not in Commercial Distribution

  • 07340074600267 ()


  • Voice synthesizer/digitizer
Single-Use Video Bronchoscope:Maximum insertion portion width is 4.4mm, minimum instrument channel width is 1.2mm,working length 600mm.
Micro-Tech (Nanjing) Co., Ltd.
SVB11001
In Commercial Distribution

  • 16932503571118 ()
  • 06932503571111 ()
  • 26932503571115 ()

  • Outer Diameter: 4.4 Millimeter
  • Pore Size: 1.2 Millimeter
  • Catheter Working Length: 600 Millimeter


  • Flexible video bronchoscope, single-use
The DGH1500-50 is a 50 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
DGH TECHNOLOGY INC.
DGH1500-50
In Commercial Distribution

  • 00857377006162 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH1500-35 is a 35 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
DGH TECHNOLOGY INC.
DGH1500-35
In Commercial Distribution

  • 00857377006155 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The Replacement Pad Set is used with PowerLift Freedom Stirrups (pair) - Bariatric 800 pound is used with
STERIS CORPORATION
Stirrup Pad
In Commercial Distribution

  • 00724995217273 ()
BF866

  • Heel stirrup cushion/pad, reusable
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