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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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PNEUMOSTOP® PLUS DEVICE
LSI Solutions, Inc.
110230
In Commercial Distribution

  • 10850012846014 ()
  • 00850012846017 ()
  • 40850012846015 ()
  • 00850200006759 ()
110230

  • Laparoscopic hysterectomy vaginal occluder
PNEUMOSTOP® DEVICE
LSI Solutions, Inc.
110200
In Commercial Distribution

  • 10850012846007 ()
  • 00850012846000 ()
  • 40850012846008 ()
  • 00850200006742 ()
110200

  • Laparoscopic hysterectomy vaginal occluder
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-40
In Commercial Distribution

  • 00837654070956 ()
  • 00850012832546 ()
  • 00850012832553 ()

  • Total Volume: 40 Milliliter
  • Catheter Gauge: 7 French


  • Intra-aortic balloon catheter
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-35
In Commercial Distribution

  • 00837654076415 ()
  • 00850012832515 ()
  • 00850012832522 ()

  • Total Volume: 35 Milliliter
  • Catheter Gauge: 7 French


  • Intra-aortic balloon catheter
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 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
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