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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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Medegen Medical Products, LLC - 00700812001263

Urinal W/TransCvr Imp 50/cs 24/plt
MEDEGEN MEDICAL PRODUCTS, LLC
H149-01
In Commercial Distribution

  • 00700812001263 ()
  • 10700812001260 ()


  • Hand-held urinal, single-use

Medegen Medical Products - 00700812016427

7QT. Wash Basin Gold 50/cs 24/plt
MEDEGEN MEDICAL PRODUCTS, LLC
541-5078-0000
In Commercial Distribution

  • 10700812016424 ()
  • 00700812016427 ()
541-5078-0000

  • Washbowl, reusable

DEKNATEL - 14026704602411

Nylon Black Monofilament Size 3-0 24" T-2 Needle
TELEFLEX INCORPORATED
IPN000846
In Commercial Distribution

  • 34026704602415 ()
  • 14026704602411 ()

  • Suture length 24", Needle length .700"
0100019-540

  • Nylon suture, non-bioabsorbable, monofilament

DEKNATEL - 14026704590299

TEV WH BR 5-0 AT-6 2N 24" PFS
TELEFLEX INCORPORATED
IPN009776
In Commercial Distribution

  • 34026704590293 ()
  • 14026704590299 ()
  • 04026704590292 ()

  • Length: 60 Centimeter
  • TEVDEK® II /Needle AT-6, AT-6 Size-5-0
7-6595W

  • Polyester suture, non-bioabsorbable, multifilament

DEKNATEL - 14026704426055

TEV GN BR 4-0 T-2 2N 24"X6
TELEFLEX INCORPORATED
IPN026799
In Commercial Distribution

  • 34026704426059 ()
  • 14026704426055 ()
  • 04026704426058 ()

  • TEVDEK® II /Needle T-2, T-2 Size-4-0
  • Length: 60 Centimeter
X-3314M6

  • Polyester suture, non-bioabsorbable, multifilament

eSensor® XT-8 - 00857167005245

eSensor® Warfarin Sensitivity Test Amplification Reagents (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005245 ()
MT002001

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

eSensor® XT-8 - 00857167005153

eSensor® Cystic Fibrosis (CF) Genotyping Test (24)
GENMARK DIAGNOSTICS, INC.
eSensor® Cystic Fibrosis (CF)
Not in Commercial Distribution

  • 00857167005153 ()
MT002015

  • Cystic fibrosis IVD, kit, multiplex

eSensor® XT-8 - 00857167005061

eSensor® Warfarin Sensitivity Test Cartridges (WST) (24)
GENMARK DIAGNOSTICS, INC.
Warfarin Sensitivity Test (WST)
Not in Commercial Distribution

  • 00857167005061 ()
MT002000

  • Cytochrome P450 (CYP450) gene polymorphism IVD, kit, multiplex

HIgH-Flo™ Needle Set - 00659443000612

24 Gauge Needle Sets - 3 needles - 6 mm
REPRO MED SYSTEMS, INC.
RMS32406
In Commercial Distribution

  • 10659443000619 ()
  • 00659443000612 ()

  • Needle Gauge: 24 Gauge
RMS32406

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000605

24 Gauge Needle Sets - 2 needles - 14 mm
REPRO MED SYSTEMS, INC.
RMS22414
In Commercial Distribution

  • 10659443000602 ()
  • 00659443000605 ()

  • Needle Gauge: 24 Gauge
RMS22414

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000599

24 Gauge Needle Sets - 2 needles - 12 mm
REPRO MED SYSTEMS, INC.
RMS22412
In Commercial Distribution

  • 10659443000596 ()
  • 00659443000599 ()

  • Needle Gauge: 24 Gauge
RMS22412

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000582

24 Gauge Needle Sets - 2 needles - 9 mm
REPRO MED SYSTEMS, INC.
RMS22409
In Commercial Distribution

  • 10659443000589 ()
  • 00659443000582 ()

  • Needle Gauge: 24 Gauge
RMS22409

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000575

24 Gauge Needle Sets - 2 needles - 6 mm
REPRO MED SYSTEMS, INC.
RMS22406
In Commercial Distribution

  • 10659443000572 ()
  • 00659443000575 ()

  • Needle Gauge: 24 Gauge
RMS22406

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000568

24 Gauge Needle Sets - 1 needle - 14 mm
REPRO MED SYSTEMS, INC.
RMS12414
In Commercial Distribution

  • 10659443000565 ()
  • 00659443000568 ()

  • Needle Gauge: 24 Gauge
RMS12414

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000551

24 Gauge Needle Sets - 1 needle - 12 mm
REPRO MED SYSTEMS, INC.
RMS12412
In Commercial Distribution

  • 10659443000558 ()
  • 00659443000551 ()

  • Needle Gauge: 24 Gauge
RMS12412

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000544

24 Gauge Needle Sets - 1 needle - 9 mm
REPRO MED SYSTEMS, INC.
RMS12409
In Commercial Distribution

  • 10659443000541 ()
  • 00659443000544 ()

  • Needle Gauge: 24 Gauge
RMS12409

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000537

24 Gauge Needle Sets - 1 needle - 6 mm
REPRO MED SYSTEMS, INC.
RMS12406
In Commercial Distribution

  • 10659443000534 ()
  • 00659443000537 ()

  • Needle Gauge: 24 Gauge
RMS12406

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000674

24 Gauge Needle Sets - 4 needles - 12 mm
REPRO MED SYSTEMS, INC.
RMS42412
In Commercial Distribution

  • 10659443000671 ()
  • 00659443000674 ()

  • Needle Gauge: 24 Gauge
RMS42412

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000667

24 Gauge Needle Sets - 4 needles - 9 mm
REPRO MED SYSTEMS, INC.
RMS42409
In Commercial Distribution

  • 10659443000664 ()
  • 00659443000667 ()

  • Needle Gauge: 24 Gauge
RMS42409

  • Subcutaneous infusion/injection port needle

HIgH-Flo™ Needle Set - 00659443000650

24 Gauge Needle Sets - 4 needles - 6 mm
REPRO MED SYSTEMS, INC.
RMS42406
In Commercial Distribution

  • 10659443000657 ()
  • 00659443000650 ()

  • Needle Gauge: 24 Gauge
RMS42406

  • Subcutaneous infusion/injection port needle
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