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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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POLE CLAMP SP
B. BRAUN MEDICAL INC.
8713130
In Commercial Distribution

  • 04045928000202 ()
8713130

  • Frame/rail/pole device holder
Manoscan Cart
Given Imaging, Inc.
FGS-8038
In Commercial Distribution

  • 10884521853317 ()

  • Power Force,120/240,Volt;Frequency,50/60,HZ,Current,5.2/2.6,AMP;


  • Manometric gastrointestinal motility analysis system
SB Capsule Endoscopy Kit
Given Imaging, Inc.
FGS-0689
In Commercial Distribution

  • 20884521845845 ()
  • 10884521845848 ()


  • Video capsule endoscopy system capsule
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
A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.
CREO MEDICAL LIMITED
Interface Cable
In Commercial Distribution

  • 05060359560070 ()
7-RS2-210

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