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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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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™ 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™ 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™ 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
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
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
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