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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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Visual-ICE™ MRI Mobile Connection Panel
BOSTON SCIENTIFIC CORPORATION
H7493970071000
In Commercial Distribution

H7493970071000

  • General cryosurgical system, cryogen gas, electronic
Visual-ICE™ MRI Junction Box Assembly
BOSTON SCIENTIFIC CORPORATION
H7493969970500
In Commercial Distribution

H7493969970500

  • General cryosurgical system, cryogen gas, electronic
Visual-ICE™ MRI Cryoablation Console
BOSTON SCIENTIFIC CORPORATION
H7493961070000
In Commercial Distribution

H7493961070000

  • General cryosurgical system, cryogen gas, electronic
EndoArmor Gown
BOSTON SCIENTIFIC CORPORATION
SGE-368-10
In Commercial Distribution

  • 00816849010281 ()
  • 08714729989332 ()
  • 08714729989592 ()
SGE-368-10

  • Isolation gown, single-use
Polyp trap
BOSTON SCIENTIFIC CORPORATION
STE-297-50
In Commercial Distribution

  • 00816849010182 ()
  • 00840253111586 ()


  • Surgical suction system collection container, single-use
Endoscope Transport
BOSTON SCIENTIFIC CORPORATION
SPX-017-25
In Commercial Distribution

  • 00816849010045 ()
  • 08714729989561 ()
SPX-017-25

  • Instrument hygienic-transportation bag
EndoArmor Gown, Plus
BOSTON SCIENTIFIC CORPORATION
SGE-389-10
In Commercial Distribution

  • 00816849016481 ()
  • 08714729989349 ()
  • 08714729989608 ()
SGE-389-10

  • Isolation gown, single-use
Air/water and Suction Valve
BOSTON SCIENTIFIC CORPORATION
SUV-617
In Commercial Distribution

  • 00840253111012 ()
  • 00840253111005 ()


  • Endoscope channel support kit
Retrieval Device
BOSTON SCIENTIFIC CORPORATION
DGN-538
In Commercial Distribution

  • 10840253107425 ()
  • 00840253107428 ()


  • Gastrointestinal/airway foreign body retrieval basket, single-use
Suture Sleeves
BOSTON SCIENTIFIC CORPORATION
6403
In Commercial Distribution

  • 00802526497827 ()
  • 00802526620607 ()


  • Pacing/defibrillation lead suture sleeve
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