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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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Freezor® Xtra - 00613994610812

CATH 227F3 FREEZOR XTRA3 SURGICAL MED7F
MEDTRONIC, INC.
227F3
Not in Commercial Distribution

  • 00613994610812 ()

  • Catheter curve size 55 mm
  • Catheter tip size 6 mm
  • Catheter shaft size 7 Fr
  • Length: 108.0 Centimeter


  • Cardiac cryosurgical system catheter

NA - 00613994610690

CABLE 2035U ELECTRICAL UMBILICAL
MEDTRONIC, INC.
2035U
Not in Commercial Distribution

  • 00613994610690 ()


  • Electrical-only medical device connection cable, single-use

NA - 00613994610676

CABLE 2035W ECG
MEDTRONIC, INC.
2035W
Not in Commercial Distribution

  • 00613994610676 ()


  • Electrocardiographic lead set, reusable

NA - 00613994610652

CABLE 203CX COAXIAL UMBILICAL
MEDTRONIC, INC.
203CX
Not in Commercial Distribution

  • 00613994610652 ()


  • Liquid nitrous oxide coaxial tubing

NA - 00643169496095

BOX 2037A AUTO CONNECTION BOX
MEDTRONIC, INC.
2037A
In Commercial Distribution

  • 00643169496095 ()


  • Cardiac cryosurgical system

NA - 00643169495807

CABLE 2035W ECG ROHS
MEDTRONIC, INC.
2035W
In Commercial Distribution

  • 00643169495807 ()


  • Electrocardiographic lead set, reusable

NA - 00643169495791

FOOTSWITCH 104FS CRYOCONSOLE ROHS
MEDTRONIC, INC.
104FS
In Commercial Distribution

  • 00643169495791 ()


  • Foot-switch, electrical

Mara - 00888937026887

Mara Water Vapor Probe Kit
Coopersurgical, Inc.
DDK-16-050
In Commercial Distribution



  • Water vapour endometrial-ablation applicator

Her Option - 00888937000016

Her Option Console
Coopersurgical, Inc.
CG-1
In Commercial Distribution

  • 00888937000016 ()


  • General cryosurgical system, cryogen gas, electronic

Paradise® Generator - 00810008950128

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
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