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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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Colon Cleansing Nozzle with Flex Tube - B149SP0001

Colon Cleansing Nozzle with Flex Tube
LIFESTREAM PURIFICATION SYSTEM LLC
SP0001
In Commercial Distribution

  • B149SP00011 ()
  • B149SP0001 ()
  • SP00010 ()
SP0001

  • Colonic lavage nozzle, sterile

N/A - 00817470008241

TOOTHLESS SHARK (ATRAUMATIC GRASPER)
Smith & Nephew, Inc.
14-2008
In Commercial Distribution

  • 00817470008241 ()
14-2008

  • Dissection forceps

N/A - 00817470008227

REPAIR JAWS GREAT WHITE GRASPER
Smith & Nephew, Inc.
14-2004R
In Commercial Distribution

  • 00817470008227 ()
14-2004R

  • Dissection forceps

N/A - 00817470008210

JAWS GREAT WHITE GRASPER
Smith & Nephew, Inc.
14-2004
In Commercial Distribution

  • 00817470008210 ()
14-2004

  • Dissection forceps

N/A - 00817470008173

JAWS RETRO TOOTHED GRASPER 2.7MM STRAIGH
Smith & Nephew, Inc.
14-2002
In Commercial Distribution

  • 00817470008173 ()
14-2002

  • Dissection forceps

N/A - 00817470008166

REPAIR JAWS TIGER SHARK GRASPER
Smith & Nephew, Inc.
14-2001R
In Commercial Distribution

  • 00817470008166 ()
14-2001R

  • Dissection forceps

N/A - 00817470007121

MEGA MOUTH GRASPER
Smith & Nephew, Inc.
14-2007
In Commercial Distribution

  • 00817470007121 ()
14-2007

  • Dissection forceps

N/A - 00817470007114

JAWS TIGER SHARK GRASPER
Smith & Nephew, Inc.
14-2001
In Commercial Distribution

  • 00817470007114 ()
14-2001

  • Dissection forceps

Dario Blood Glucose Monitoring System - 00850065006000

The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.
LABSTYLE INNOVATION LTD
1015-01
In Commercial Distribution

  • 00850065006000 ()


  • Home-use/point-of-care blood glucose/blood pressure monitoring system

Pointe G6PD Reagent - 00811727014139

Pointe G6PD Reagent, 10 x 6ml, 1 x 120ml kit, For the quantitative, kinetic determination of glucose-6-phosphate dehydrogenase (G6PD) in blood at 340 nm. For in vitro diagnostic use only.
POINTE SCIENTIFIC, INC.
G7583-180
In Commercial Distribution

  • 00811727014139 ()
G7583-180

  • Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, kit, enzyme spectrophotometry
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