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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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uOmnispace - 06971576834259

No Description
Shanghai United Imaging Healthcare Co., Ltd.
uOmnispace.MR
In Commercial Distribution

  • 06971576834259 ()


  • MRI system application software

BioJet Target - 04260476810015

Software for biopsy needle guide planning and tracking.
MTT GmbH
3
In Commercial Distribution

  • 04260476810015 ()


  • Brachytherapy system application software

Nexstim NBS Black Head Tracker - 06430063200125

Nexstim NBS Black Head Tracker (box of 4), new part list NX103355
Nexstim Oyj
NX92465
In Commercial Distribution

  • 06430063200125 ()
NX103377

  • Stereotactic neuronavigation/planning system
  • Hand-held deep-tissue electromagnetic stimulator
  • Electromyograph

MIDMARK IQHOLTER® PLUG-IN SOFTWARE - 00841709118067

IQ HOLTER PLUG-IN SOFTWARE v10.0.6: New Software Release for Midmark Digital Holter.
MIDMARK CORPORATION
P/N 4-100-3140
In Commercial Distribution

  • 00841709118067 ()


  • Electrocardiographic long-term ambulatory recording analyser

Ventlab - 10889483097991

INFANT W/MANOMETER,12" CORRUGATED RESERVOIR,M1 MASK & NEW STYLE O2 RESERV
VENTLAB, LLC
VN3106MC-M1V
In Commercial Distribution

  • 20889483097998 ()
  • 10889483097991 ()

  • Total Volume: 300 Milliliter


  • Pulmonary resuscitator, manual, single-use

KLARITY MEDICAL - 00817355027961

Klarity Customized Head Mold 15x31cm with New Neck Flare and 6cm bump
Klarity Medical Products, LLC
R550-PS45
In Commercial Distribution

  • 00817355027961 ()


  • Patient positioning foam mould kit

MediMax Tech - 00817325022903

OMX52P Split Horizontal Corded Foam Grounding Plate- New Oversized Gel -Single Pack
MEDIMAX TECH INC.
OMX52P ESU Plate
In Commercial Distribution

  • 20817325022907 ()
  • 10817325022900 ()
  • 00817325022903 ()


  • Electrosurgical return electrode, single-use

BOSS Instruments - 00888515299733

Image-Line, micro blade, short teeth, 14x60mm, Blue Titanium Blade, New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6151TH
In Commercial Distribution

  • 00888515299733 ()
73-6151TH

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515299726

Image-Line, micro blade, short teeth, 14x55mm, Blue Titanium Blade, New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6150TH
In Commercial Distribution

  • 00888515299726 ()
73-6150TH

  • Surgical retractor/retraction system blade, reusable

BOSS Instruments - 00888515299719

Image-Line, micro blade, short teeth, 14x50mm, Blue Titanium Blade, New Locking Hub
BOSS INSTRUMENTS, LTD., INC.
73-6149TH
In Commercial Distribution

  • 00888515299719 ()
73-6149TH

  • Surgical retractor/retraction system blade, reusable
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