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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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RHYTHMIA HDx™ - 08714729994077

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004RBINSTALL2ENR0
In Commercial Distribution

  • 08714729994077 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729986003

Ablation Connection Box (SmartAblate)
BOSTON SCIENTIFIC CORPORATION
M004RA64030
In Commercial Distribution

  • 08714729986003 ()


  • Cardiac mapping system

RHYTHMIA HDx™ - 08714729985983

Ablation Connection Box (IBI/Ampere)
BOSTON SCIENTIFIC CORPORATION
M004RA61030
In Commercial Distribution

  • 08714729985983 ()


  • Cardiac mapping system

Osstem - 08800000995014

The Portable X-ray System (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
Osstem Implant Co., Ltd._Gasan Branch
EXARO
In Commercial Distribution

  • 08800000995014 ()


  • Portable basic diagnostic x-ray system, digital

MP21 MR Coil Kit - 04056869049625

Contains Medical Device Mat. 8635612 (GTIN:04056869038858)
Siemens Shenzhen Magnetic Resonance Ltd.
10019213
In Commercial Distribution

  • 04056869049625 ()


  • Full-body MRI system, permanent magnet

Extremity small coil kit - 04056869049618

Contains Medical Device Mat. 8635596 (GTIN:04056869038834)
Siemens Shenzhen Magnetic Resonance Ltd.
10019208
In Commercial Distribution

  • 04056869049618 ()


  • Full-body MRI system, permanent magnet

Extremity L MR Coil Kit - 04056869049601

Contains Medical Device Mat. 8635588 (GTIN:04056869038827)
Siemens Shenzhen Magnetic Resonance Ltd.
10019205
In Commercial Distribution

  • 04056869049601 ()


  • Full-body MRI system, permanent magnet

Extremity XL MR Coil Kit - 04056869049595

Contains Medical Device Mat. 8635570 (GTIN:04056869038810)
Siemens Shenzhen Magnetic Resonance Ltd.
10019204
In Commercial Distribution

  • 04056869049595 ()


  • Full-body MRI system, permanent magnet

MP16 MR Coil Kit - 04056869049588

Contains Medical Device Mat. 8635604 (GTIN:04056869038841)
Siemens Shenzhen Magnetic Resonance Ltd.
10019203
In Commercial Distribution

  • 04056869049588 ()


  • Full-body MRI system, permanent magnet

Body Spine Array XXL MR Coil Kit - 04056869049571

Contains Medical Device Mat. 8635505 (GTIN:04056869038766)
Siemens Shenzhen Magnetic Resonance Ltd.
10019202
In Commercial Distribution

  • 04056869049571 ()


  • Full-body MRI system, permanent magnet
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