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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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48" SMOOTH-INTERIOR, SMOOTH-TIP DISPOSABLE KIT
QUALITY MEDICAL SUPPLY, INC.
01
In Commercial Distribution

  • 00850014947002 ()
148

  • Colonic lavage kit, non-surgical
jFit Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885021 ()


  • Ultrasound imaging system application software
3D Echo Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885007 ()


  • Ultrasound imaging system operation software
4 Pack Silicone Strips, 5.7" x 1.57" (15cm x 4cm)
Biodermis LLC
SCCS-4
In Commercial Distribution

  • 00850014883287 ()
  • 00850014883294 ()
SCCS-4

  • Scar-management dressing, reusable
1 Silicone Roll, 1.5" x 120" (4cm x 300cm)
Biodermis LLC
SCCR-120
In Commercial Distribution

  • 00850014883270 ()
SCCR-120

  • Scar-management dressing, reusable
Scar Aid Silicone Stick SPF 17g
Biodermis LLC
SCSTSP17-US
In Commercial Distribution

  • 00850014883201 ()
SCSTSP17-US

  • Scar-management dressing, reusable
Scar Aid Silicone Stick SPF 4.25g
Biodermis LLC
SCSTSP-US
In Commercial Distribution

  • 00850014883195 ()
SCSTSP-US

  • Scar-management dressing, reusable
SCAR AID SILICONE STICK 17g
Biodermis LLC
SCST17-US
In Commercial Distribution

  • 00850014883188 ()
SCST17-US

  • Scar-management dressing, reusable
Scar Aid Silicone Stick 4.25g
Biodermis LLC
SCST-US
In Commercial Distribution

  • 00850014883171 ()
SCST-US

  • Scar-management dressing, reusable
Therafoam Uncoated Wraps 6 Pack
Biodermis LLC
TRRU-6
In Commercial Distribution

  • 00850014883133 ()
TRRU-6

  • Scar-management dressing, reusable
Therafoam Uncoated Wraps 1 Pack
Biodermis LLC
TRRU-1
In Commercial Distribution

  • 00850014883126 ()
TRRU-1

  • Scar-management dressing, reusable
Camo Pink, 1 Sheet 2.75" x 1.18".
Biodermis LLC
CDG-P1
In Commercial Distribution

  • 00850014883065 ()
CDG-P1

  • Scar-management dressing, reusable
Camo Green, 1 Sheet 2.75" x 1.18".
Biodermis LLC
CDG-G1
In Commercial Distribution

  • 00850014883058 ()
CDG-G1

  • Scar-management dressing, reusable
TNT Patch 2" x 2.5". 1 Patch
Biodermis LLC
EDGTNT-23
In Commercial Distribution

  • 00850014883041 ()
EDGTNT-23

  • Scar-management dressing, reusable
Fabric Strip 1.4" x 11.5". 1 Strip
Biodermis LLC
FDG-112
In Commercial Distribution

  • 00850014883034 ()
FDG-112

  • Scar-management dressing, reusable
TNT Strip 1.4" x 11.5". 1 Strip
Biodermis LLC
EDGTNT-112
In Commercial Distribution

  • 00850014883027 ()
EDGTNT-112

  • Scar-management dressing, reusable
TNT Silicone Strip 1.4" x 6.0". 2 Strips
Biodermis LLC
EDGTNT-2106
In Commercial Distribution

  • 00850014883010 ()
EDGTNT-2106

  • Scar-management dressing, reusable
No Description
Hearts Bio, Inc.
TD-4289
In Commercial Distribution

  • 00850014861629 ()


  • Glucose IVD, kit, electrometry
No Description
Hearts Bio, Inc.
TD-4289
In Commercial Distribution

  • 00850014861537 ()


  • Lactate IVD, reagent
No Description
Hearts Bio, Inc.
TD-4289
In Commercial Distribution

  • 00850014861407 ()


  • Lactate IVD, reagent
No Description
Hearts Bio, Inc.
TD-4289
In Commercial Distribution

  • 00850014861360 ()


  • Lactate IVD, reagent
No Description
Hearts Bio, Inc.
TD-4289
In Commercial Distribution

  • 00850014861353 ()


  • Uric acid IVD, reagent
No Description
Hearts Bio, Inc.
TD-4289
In Commercial Distribution

  • 00850014861346 ()


  • Total cholesterol lipid IVD, reagent
No Description
Hearts Bio, Inc.
TD-4289
In Commercial Distribution

  • 00850014861056 ()


  • Multiple clinical chemistry analyser IVD, home-use
No Description
Hearts Bio, Inc.
TD-4289
In Commercial Distribution

  • 00850014861049 ()


  • Total cholesterol lipid IVD, reagent
Soovu Pain Relief System is a kit branded as Soovu Heatwave Therapy and includes two 2" x 2" pods/heaters that, when adhered to user's skin via disposable adhesive rings, provide pulsed heat at controlled temperatures for set therapy durations. The pods are Bluetooth-paired with, and controlled via, a mobile device application (Soovu on iOS or Android) from which the user also administers the heat therapy sessions. The Soovu Heatwave Therapy Kit includes 2 heating pods, 1 dual-pod charging cradle, 1 USB charging cable, 60 'Daily' adhesives, carry case, and Quick Start Guide.
Soovu Labs, Inc.
SL-WPTKIT-01
In Commercial Distribution

  • 00850014805005 ()


  • Electric pad localized-body heating system
NATALIST PREGNANCY TEST STRIP 15 COUNT is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 15pcs of 5mm strips in each box.
Equinox Biotech Co., Ltd.
58431
In Commercial Distribution

  • 00850014758431 ()
RH-HCG-S

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
NATALIST EARLY Pregnancy Test is a self-testing rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. There are 4pcs of midstream in each box.
Equinox Biotech Co., Ltd.
8363
In Commercial Distribution

  • 00850014758363 ()
  • 00850014758127 ()
RH-HCG-B

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
NATALIST PREGNANCY TEST MIDSTREAM 2 COUNT is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 2pcs of 6mm midstreams in one box.
Equinox Biotech Co., Ltd.
58257
In Commercial Distribution

  • 00850014758257 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
NATALIST OVULATION TEST STRIP 30 COUNT is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. There are 30pcs of 5mm strips in each box.
Equinox Biotech Co., Ltd.
58240
In Commercial Distribution

  • 00850014758240 ()
RH-LH-S

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
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