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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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Quantum Workstation
SPECTRUM MEDICAL LIMITED
QWS
In Commercial Distribution

  • 05060434420008 ()
51-000001-00

  • Extracorporeal blood gas/pH monitor
NOVII INTERFACE CABLE - GE UA
Datex-Ohmeda, Inc.
GE UA
In Commercial Distribution

  • 05060433670138 ()
105-PT-106

  • Electrical-only medical device connection cable, reusable
Monica Interface CTG Cable - GE Corometrics MECG round green connector
Datex-Ohmeda, Inc.
GE MECG
In Commercial Distribution

  • 05060433670114 ()
105-PT-104

  • Electrical-only medical device connection cable, reusable
NOVII INTERFACE CABLE - GE FECG
Datex-Ohmeda, Inc.
GE FECG
In Commercial Distribution

  • 05060433670091 ()
105-PT-102

  • Electrical-only medical device connection cable, reusable
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
7-EMR-050 V6.001
In Commercial Distribution

  • 05060359560919 ()
  • 05060359560926 ()
  • 05060359560513 ()
7-EMR-050

  • Microwave/electrosurgical system generator
A sterile, flexible, invasive, endoscopic device assembly intended to deliver: 1) a submucosal lifting solution; 2) an electrosurgical current in a bipolar configuration to tissues for cutting; and 3) microwave energy to tissues for coagulation. It is typically intended to treat gastrointestinal mucosal polyps/lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent electrosurgical excision of the diseased area. It includes a submucosal injection needle, an electrosurgical electrode, and a microwave tip, connected by a flexible sheath to a handpiece which includes controls (e.g., needle deployment control)/solution injection port. This is a single-use device.
CREO MEDICAL LIMITED
7-RS2-003
In Commercial Distribution

  • 05060359560599 ()
  • 05060359560575 ()

  • Outer Diameter: 2.65 Millimeter
  • Catheter Length: 2.3 Meter
7-RS2-003

  • Endoscopic electrosurgical/microwave submucosal lift/resection instrument
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
7-EMR-050 V6.01
In Commercial Distribution

  • 05060359560513 ()
7-EMR-050

  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Croma Generator V4.0
In Commercial Distribution

7-EMR-050

  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Generator 7-EMR-050 with Footswitch 2-EMR-050
Not in Commercial Distribution

  • 05060359560124 ()


  • Microwave/electrosurgical system generator
A mains electricity-powered (AC-powered) component of a microwave ablation/electrosurgical system intended to generate both: 1) radio-frequency (RF) electrical current; and 2) microwave energy for subsequent cutting, coagulation, and ablation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues. It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for argon-enhanced electrosurgery.
CREO MEDICAL LIMITED
Generator 7-EMR-050
Not in Commercial Distribution

  • 05060359560087 ()


  • Microwave/electrosurgical system generator
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