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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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miniARM® multiSTATION™ System - 00850012846093

M45™ CLICK RELEASE™ miniARM® Holder
LSI Solutions, Inc.
081010
In Commercial Distribution

  • 00850012846093 ()
081010

  • Surgical instrument assist arm system structural component

VALVEVAULT™ - 00850012846086

VALVEVAULT™ DEVICE KIT This kit includes one (1) each non-sterile, reusable VALVEVAULT™ DEVICE (S), (M), (L), all of which have Direct Marking.
LSI Solutions, Inc.
081040
In Commercial Distribution

  • 00850012846086 ()

  • (S) Chambers - Diameter: 19, 21 mm; Depth: 11.5, 12.5 mm (M) Chambers - Diameter: 23, 25 mm; Depth: 13.5, 14.5 mm (L) Chambers - Diameter: 27, 29 mm; Depth: 15.5, 16.2 mm
081040

  • Heart valve prosthesis holder, reusable

VALVEVAULT™ - 00850012846079

VALVEVAULT™ DEVICE (L) 27mm / 29mm
LSI Solutions, Inc.
081035
In Commercial Distribution

  • 00850012846079 ()

  • VALVEVAULT™ (L) Chamber Diameters: 27, 29 mm Chamber Depth: 15.5, 16.2 mm
081035

  • Heart valve prosthesis holder, reusable

VALVEVAULT™ - 00850012846062

VALVEVAULT™ DEVICE (M) 23mm / 25mm
LSI Solutions, Inc.
081030
In Commercial Distribution

  • 00850012846062 ()

  • VALVEVAULT™ (M) Chamber Diameters: 23, 25 mm Chamber Depth: 13.5, 14.5 mm
081030

  • Heart valve prosthesis holder, reusable

VALVEVAULT™ - 00850012846055

VALVEVAULT™ DEVICE (S) 19mm / 21mm
LSI Solutions, Inc.
081025
In Commercial Distribution

  • 00850012846055 ()

  • VALVEVAULT™ (S) Chamber Diameters: 19, 21 mm Chamber Depth: 11.5, 12.5 mm
081025

  • Heart valve prosthesis holder, reusable

Mi-CHORD™ - 00850012846048

Mi-CHORD™ SYSTEM
LSI Solutions, Inc.
032150
In Commercial Distribution

  • 10850012846045 ()
  • 00850012846048 ()
032150

  • Suturing unit, single-use

PNEUMOSTOP® - 00850012846017

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

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

  • Laparoscopic hysterectomy vaginal occluder

PNEUMOSTOP® - 00850012846000

PNEUMOSTOP® DEVICE
LSI Solutions, Inc.
110200
In Commercial Distribution

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

  • Laparoscopic hysterectomy vaginal occluder

Ultra IABP Catheter Kit - 00850012832546

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

Ultra IABP Catheter Kit - 00850012832515

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
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