INSIGHTRA MEDICAL, INC.

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• insightra.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20

  2009-01-12

  INSIGHTRA MEDICAL, INC.

GUDID#

• Modulare Stabilization Device - The Modulare System is used to secure various types of catheters to the patient’s skin. The device uses a post and securement cover to attach itself to either the suture tab of the catheter or mating hole on Modulare accessories. An adhesive base secures the Modulare system to the patient to allow for safe and secure placement of the catheter onto the patient. The Modulare system is disposable and designed to be placed on the patient for a time to not to exceed 7 days.

  INSIGHTRA MEDICAL, INC.

  2015-03-16

• Modulare Stabilization Device - The Modulare System is used to secure various types of catheters to the patient’s skin. The device uses a post and securement cover to attach itself to either the suture tab of the catheter or mating hole on Modulare accessories. An adhesive base secures the Modulare system to the patient to allow for safe and secure placement of the catheter onto the patient. The Modulare system is disposable and designed to be placed on the patient for a time to not to exceed 7 days.

  INSIGHTRA MEDICAL, INC.

  2015-03-16

• Freedom - ProFlor Inguinal Hernia Implant - The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device, sold separately, is used to deploy the implant into the prepared hernia defect site.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - ProFlor Inguinal Hernia Implant - The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device, sold separately, is used to deploy the implant into the prepared hernia defect site.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - ProFlor Inguinal Hernia Implant - The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device, sold separately, is used to deploy the implant into the prepared hernia defect site.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - Ventral Hernia Repair System - The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene Octomesh™ implant and a disposable strap passer. The implant has a central body with 8 radiating straps. The straps pass through the abdominal wall and hold the body of the mesh in place.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - Ventral Hernia Repair System - The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene Octomesh™ implant and a disposable strap passer. The implant has a central body with 8 radiating straps. The straps pass through the abdominal wall, leaving them lying in tissue tunnels created by the passer. The straps hold the body of the mesh in place.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - Ventral Hernia Repair System - The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene Octomesh™ implant and a disposable strap passer. The implant has a central body with 8 radiating straps. The straps pass through the abdominal wall, leaving them lying in tissue tunnels created by the passer. The straps hold the body of the mesh in place.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - ProFlor Inguinal Hernia Implant - The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device, sold separately, is used to deploy the implant into the prepared hernia defect site.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - Ventral Hernia Repair System - The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene Octomesh™ implant and a disposable strap passer. The implant has a central body with 8 radiating straps. The straps pass through the abdominal wall, leaving them lying in tissue tunnels created by the passer. The straps hold the body of the mesh in place.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - Ventral Hernia Repair System - The Freedom™ Ventral Hernia Repair System consists of a synthetic and permanent polypropylene Octomesh™ implant and a disposable strap passer. The implant has a central body with 8 radiating straps. The straps pass through the abdominal wall, leaving them lying in tissue tunnels created by the passer. The straps hold the body of the mesh in place.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - ProFlor Inguinal Hernia Kit - The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device is used to deploy the implant into the prepared hernia defect site.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - ProFlor Inguinal Hernia Kit - The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device is used to deploy the implant into the prepared hernia defect site.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - ProFlor Inguinal Hernia Kit - The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device is used to deploy the implant into the prepared hernia defect site.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• Freedom - ProFlor Inguinal Hernia Kit - The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device is used to deploy the implant into the prepared hernia defect site.

  INSIGHTRA MEDICAL, INC.

  2015-07-22

• PowerPumpTM dp System Day Cassette - 941012

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System Patient cassette - 941013

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System Patient tubing - 941014

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• Double Pump Day cassette/ Double Pump RF Day cassette - 1002053

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• Double Pump Single/ Double Pump RF Single - 1002052

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• Double Pump Patient cassette - 1002059

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• Double Pump RF Patient cassette - 1003059

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System - 941010

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System Power Pump dp HP Interface Box Type 1 - 941038G

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System Foot Control - 941040

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System Power Pump dp HP Interface Box Type 2 - 941015G

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System Power Pump dp HP Interface Box Type 3 - 941023G

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System Power Pump dp HP Interface Box Type 4 - 941025G

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• owerPumpTM dp System Interface Cable, Type 2 - Compatible with: ConMed Advtg

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System Interface Cable, Type 5 - Compatible with: Arthrex APS

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System Interface Cable, Type 6 - Compatible with: Atlantech Revlt

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System Interface Cable, Type 3 - Compatible with: BSM PowerTek II Pls

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• PowerPumpTM dp System Interface Cable, Type 1 - Compatible with: S&N Dyonics Power, Dyonics Power 2

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• Double Pump RF - 1028511

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• Foot Control 4-pedal - For Double Pump RF or Double Pump

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• Foot Control 2-pedal - For Double Pump RF or Double Pump

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• Shaver Interface Box B1 - For connecting Double Pump RF or Double Pump to ConMed-Linvatec Advantage D 3000; red shaver port

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• Shaver Interface Box B2 - For connecting Double Pump RF or Double Pump to S&N Dyonics Power, S&N Dyonics Power II

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• Shaver Interface Box B5 - For connecting Double Pump RF or Double Pump to BSM PowerTek II Plus, Stryker TPS, Stryker Core

  INSIGHTRA MEDICAL, INC.

  2016-09-24

• Shaver Interface Box B6 - For connecting Double Pump RF or Double Pump to Arthrex APS II, Atlantech Revolution, FMS Duo+

  INSIGHTRA MEDICAL, INC.

  2016-09-24

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