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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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PT9 Therapy System
THERMOTEK, INC.
0P9PT09SYS
In Commercial Distribution

  • B5850P9PT09SYS0 ()
0P9PT09SYS

  • Single-chamber venous compression system garment, reusable
  • Circulating-fluid localized thermal therapy system pack, single-use
  • Circulating-fluid localized thermal/compression therapy system wrap
  • Circulating-fluid localized thermal/compression therapy system control unit
VELA Diamond pediatric breathing circuit kit
Carefusion Corporation
11571
Not in Commercial Distribution

  • 10846446001693 ()
11571

  • Y-piece breathing circuit connector, single-use
  • Breathing circuit condensate trap, single-use
  • Breathing circuit catheter mount, single-use
  • Ventilator breathing circuit, single-use
Airlife™ Isothermal™ Breathing Circuit Pediatric Respiratory Circuit Heated
Carefusion Corporation
10808-H12
Not in Commercial Distribution

  • 50885403026797 ()
  • 10885403026799 ()
10808-H12

  • Ventilator breathing circuit, single-use
  • Non-heated respiratory humidifier
  • Microbial medical gas filter, single-use
  • Airway pressure monitor, non-powered
Lap Port Closure Device Kit with10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OSLPCDK15
In Commercial Distribution

  • B354OSLPCDK15 ()
OSLPCDK15

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Cell morphology analyser IVD, automated/semi-automated
3 Ring Suture Passer Kit with 10/12mm and 15mm Guides
ORANGE SURGICAL INSTRUMENTS, LLC
OS3CDK15
In Commercial Distribution

  • B354OS3CDK15 ()
OS3CDK15

  • Laparoscopic wound closure thread
  • Insufflation gas conditioning tubing set
  • Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
  • Cell morphology analyser IVD, automated/semi-automated
The Envision Platform with Forma-I, Forma, Morpheus8 and Lumecca Applicators employs two different technologies for various aesthetic applications – Intense Pulsed Light (IPL), and Radiofrequency (RF). The System operates while in contact with any of the following Handpieces: Forma-I and Forma Handpieces employs bi-polar Radiofrequency (RF) technology for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation; Lumecca IPL for treatment of superficial vascular and pigmented lesions; and Morpheus8 for electro-coagulation. The device provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for each patient and applications.
INMODE M.D LTD
AG609993A
In Commercial Distribution

  • 07290016633726 ()
AG609993A

  • Multi-modality skin surface treatment system
The InMode OP System is employing three different technologies for various aesthetic applications – Laser, Intense Pulsed Light (IPL), and Radiofrequency (RF).
INMODE M.D LTD
AG605893A
In Commercial Distribution

  • 07290019863311 ()
AG605893A

  • Multi-modality skin surface treatment system
Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit MR850
Carefusion Corporation
RC6Y104003
Not in Commercial Distribution

  • 50885403168930 ()
  • 10885403168932 ()
RC6Y104003

  • Ventilator breathing circuit, single-use
  • Metered dose inhaler
  • Breathing circuit condensate trap, reusable
  • Non-heated respiratory humidifier
Airlife™ Isothermal Breathing Circuit Pediatric Respiratory Circuit Heated
Carefusion Corporation
10863-H12
Not in Commercial Distribution

  • 50885403168541 ()
  • 10885403168543 ()
10863-H12

  • Non-heated respiratory humidifier
  • Ventilator breathing circuit, single-use
  • Inhalation-therapy adaptor, single-use
  • Airway pressure monitor, non-powered
Airlife™ Isothermal™ Breathing Circuit Adult Respiratory Circuit MR850
Carefusion Corporation
RC6P003059
Not in Commercial Distribution

  • 50885403168503 ()
  • 10885403168505 ()
RC6P003059

  • Ventilator breathing circuit, single-use
  • Inspiratory/expiratory limb respiratory tubing, reusable
  • Airway pressure monitor, non-powered
  • Non-heated respiratory humidifier
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