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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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The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery.
INSIGHTRA MEDICAL, INC.
IMU7F-30
In Commercial Distribution

  • 00837654076439 ()
  • 00850012832485 ()
  • 00850012832492 ()

  • Catheter Gauge: 7 French
  • Total Volume: 30 Milliliter


  • Intra-aortic balloon catheter
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.
FVHR35X45
In Commercial Distribution

  • 00850012832348 ()
  • 00013964672008 ()
  • 00850012832355 ()

  • 35X45
FVHR35X45

  • Extra-gynaecological surgical mesh, composite-polymer
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.
FVHR28X35
In Commercial Distribution

  • 00837654352991 ()
  • 00850012832317 ()
  • 00850012832324 ()

  • 28X35
FVHR28X35

  • Extra-gynaecological surgical mesh, composite-polymer
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.
FVHR20X30
In Commercial Distribution

  • 00837654352984 ()
  • 00850012832287 ()
  • 00850012832294 ()

  • 20X30
FVHR20X30

  • Extra-gynaecological surgical mesh, composite-polymer
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.
FVHR15X25
In Commercial Distribution

  • 00850012832256 ()
  • 00837654352977 ()
  • 00850012832263 ()

  • 15X25
FVHR15X25

  • Extra-gynaecological surgical mesh, composite-polymer
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.
FVHR12X15
In Commercial Distribution

  • 00837654352960 ()
  • 00850012832218 ()
  • 00850012832232 ()

  • 12X15
FVHR12X15

  • Extra-gynaecological surgical mesh, composite-polymer
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.
FIHR 40mmE
In Commercial Distribution

  • 00013964672176 ()
  • 00850012832102 ()
  • 00850012832119 ()

  • Outer Diameter: 40 Millimeter
FIHR 40mmE

  • Extra-gynaecological surgical mesh, composite-polymer
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.
FIHR 40mm
In Commercial Distribution

  • 00013964672381 ()
  • 00850012832072 ()
  • 00850012832089 ()

  • Outer Diameter: 40 Millimeter
FIHR 40mm

  • Extra-gynaecological surgical mesh, composite-polymer
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.
FIHR 25mmE
In Commercial Distribution

  • 00850012832041 ()
  • 00013964672343 ()
  • 00850012832058 ()

  • Outer Diameter: 25 Millimeter
FIHR 25mmE

  • Extra-gynaecological surgical mesh, composite-polymer
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.
FIHR 25mm
In Commercial Distribution

  • 00013964672374 ()
  • 00850012832010 ()
  • 00850012832027 ()

  • Outer Diameter: 25 Millimeter
FIHR 25mm

  • Extra-gynaecological surgical mesh, composite-polymer
The CrossGlide Endometrial Tissue Sampler (ETS Plus) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting membrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplying saline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Catheter contains an acorn tip as an aid in seating its distal end at the exocervix.
CROSS BAY MEDICAL, INC.
ETS Plus
In Commercial Distribution

  • 00850012760061 ()
CBPN3003

  • Endometrial biopsy curette
The CrossGlide Endometrial Tissue Sampler (ETS) is comprised of a Delivery Catheter with a 6 Fr Biopsy Device and everting membrane that accesses the cervix and uterine cavity and a 3cc syringe with an attachable compliant tube assembly for supplying saline to the Delivery Catheter. The 3cc syringe is also used for supplying negative pressure in the ETS. The Delivery Catheter contains an acorn tip as an aid in seating its distal end at the exocervix.
CROSS BAY MEDICAL, INC.
CBPN3001
In Commercial Distribution

  • 00850012760054 ()
  • 10850012760051 ()


  • Endometrial biopsy kit
dental air Driven handpiece
Osseo Scientific LLC
NT-PG-U
In Commercial Distribution

  • 00850012724292 ()


  • Dental precision attachment fitting/adjustment tool
dental air Driven handpiece
Osseo Scientific LLC
NT-PG-III
In Commercial Distribution

  • 00850012724285 ()


  • Dental precision attachment fitting/adjustment tool
dental air Driven handpiece
Osseo Scientific LLC
NT-PG-II
In Commercial Distribution

  • 00850012724278 ()


  • Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NTS-14-FG
In Commercial Distribution

  • 00850012724261 ()


  • Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NTS-14
In Commercial Distribution

  • 00850012724254 ()


  • Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NT-PG-SNC-H
In Commercial Distribution

  • 00850012724247 ()


  • Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NT-PG-SNC-C
In Commercial Distribution

  • 00850012724230 ()


  • Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
INT-SNC
In Commercial Distribution

  • 00850012724223 ()


  • Dental precision attachment fitting/adjustment tool
dental air driven handpiece
Osseo Scientific LLC
INT-D
In Commercial Distribution

  • 00850012724216 ()


  • Dental precision attachment fitting/adjustment tool
dental air Driven handpiece
Osseo Scientific LLC
INT-E
In Commercial Distribution

  • 00850012724209 ()


  • Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NTE-14
In Commercial Distribution

  • 00850012724179 ()


  • Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NTE-11
In Commercial Distribution

  • 00850012724162 ()


  • Dental precision attachment fitting/adjustment tool
dental air Driven handpiece
Osseo Scientific LLC
NTE-M5
In Commercial Distribution

  • 00850012724155 ()


  • Dental precision attachment fitting/adjustment tool
dental air Driven handpiece
Osseo Scientific LLC
NTE-M20
In Commercial Distribution

  • 00850012724148 ()


  • Dental precision attachment fitting/adjustment tool
dental Attachement
Osseo Scientific LLC
NT-PG-SNC-M
In Commercial Distribution

  • 00850012724131 ()


  • Dental precision attachment fitting/adjustment tool
Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 27 leads, soft cup, with disposable 27 lead harness
IVES EEG SOLUTIONS, LLC
DCPEX-27/S
In Commercial Distribution

  • 00850012681250 ()
DCPEX-27/S

  • Analytical scalp electrode, single-use
Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 25 leads, soft cup, with disposable 25 lead harness
IVES EEG SOLUTIONS, LLC
DCPEX-25/S
In Commercial Distribution

  • 00850012681243 ()
DCPEX-25/S

  • Analytical scalp electrode, single-use
Disposable Conductive Plastic Electrode Set, MR/CT Compatible, 23 leads, soft cup, with disposable 23 lead harness
IVES EEG SOLUTIONS, LLC
DCPEX-23/S
In Commercial Distribution

  • 00850012681236 ()
DCPEX-23/S

  • Analytical scalp electrode, single-use
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