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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CABLE 2035W 4 LEAD CRYO ROHS CEA MDR
MEDTRONIC, INC.
2035W
In Commercial Distribution

  • 00763000306502 ()


  • Electrocardiographic lead set, reusable
BOX 2037A AUTO CONNECTION BOX MDR
MEDTRONIC, INC.
2037A
In Commercial Distribution

  • 00763000306496 ()


  • Cardiac cryosurgical system
The NovaSure®Impedance Controlled Endometrial Ablation System is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive bleeding) due to benign causes for whom childbearing is complete.
Hologic, Inc.
815012US
In Commercial Distribution

  • 25420045505398 ()
  • 15420045505391 ()
815012US

  • Radio-frequency endometrial-ablation system generator
CABLE 2035UC ELECT UMBILICAL BOX 12 BMED
MEDTRONIC, INC.
2035UC
In Commercial Distribution

  • 00763000359362 ()
  • 20763000359366 ()


  • Electrical-only medical device connection cable, single-use
CABLE 2035UC ELECT UMBILICAL BOX 12 ROHS
MEDTRONIC, INC.
2035UC
In Commercial Distribution

  • 20763000279770 ()
  • 00763000279776 ()


  • Electrical-only medical device connection cable, single-use
CABLE 203CXC COAXIAL UMBIL BOX 12 ROHS
MEDTRONIC, INC.
203CXC
In Commercial Distribution

  • 20763000279756 ()
  • 00763000279752 ()


  • Liquid nitrous oxide coaxial tubing
PRDS-USG-2X Paradise® Generator with Paradise® Remote
Recor Medical, Inc.
PRDS-USG-2X
In Commercial Distribution

  • 00810008950128 ()
PRDS-USG-2X

  • Renal denervation ultrasound system generator
PRDS-USG-2X Paradise® Generator
Recor Medical, Inc.
PRDS-USG-2X
In Commercial Distribution

  • 00810008950111 ()
PRDS-USG-2X

  • Renal denervation ultrasound system generator
PRDS-RM Paradise® Remote
Recor Medical, Inc.
PRDS-RM
In Commercial Distribution

  • 00810008950098 ()
PRDS-RM

  • Renal denervation ultrasound system generator
PRDS-CT-02 Paradise® Cartridge
Recor Medical, Inc.
PRDS-CT-02
In Commercial Distribution

  • 00810008950074 ()
  • 10810008950071 ()
PRDS-CT-02

  • Renal denervation ultrasound system cooling solution flow chamber
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