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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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Neotech Bridge® - 00812594013478

The Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest.
Neotech Products LLC
Kit – Bridge with Extension and 20ML & 60ML Syringes
In Commercial Distribution

  • 00812594013478 ()
N8001-Kit

  • Breast pump support kit, reusable

Surgical Direct - B382S34556300T0

Pre-op Toric Reference Marker, Titanium, Half Circle With 3 Points At 0, 90 and 180 Degrees On A Round Knurled Handle
Surgical Direct, Inc.
S34556.300T
In Commercial Distribution

  • B382S34556300T0 ()
S34556.300T

  • Intraocular retractor, reusable

Surgical Direct - B382S28530000

3 1/2" Utrata Forceps, Short 3-Hole Handle, Laser Lines at 2.5mm and 5.0mm, 12mm Bend to Tip, Delicate Triangular Tips
Surgical Direct, Inc.
S2853.000
In Commercial Distribution

  • B382S28530000 ()
S2853.000

  • Dressing/utility forceps, scissors-like, reusable

Vitreoretinal Viscodissector 45-Degree - 00813465011708

Dissection of vitreoretinal membranes using viscoelastic fluid. 30 gauge tip, 5mm long and angled at 45 degrees. Extension tube length 20cm.
HURRICANE MEDICAL INC
7519
In Commercial Distribution

  • 10813465011705 ()
  • 00813465011708 ()

  • Length: 33 Millimeter
  • Needle Gauge: 20 Gauge
7519

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Vitreoretinal Viscodissector 70-Degree - 00813465011692

Dissection of vitreoretinal membranes using viscoelastic fluid. 30 gauge tip, 5mm long and angled at 70 degrees. Extension tube length 20cm.
HURRICANE MEDICAL INC
7518
In Commercial Distribution

  • 10813465011699 ()
  • 00813465011692 ()

  • Length: 33 Millimeter
  • Needle Gauge: 20 Gauge
7518

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

Vitreoretinal Viscodissector 90-Degree - 00813465011685

Dissection of vitreoretinal membranes using viscoelastic fluid. 30 gauge tip, 5mm long and angled at 90 degrees. Extension tube length 20cm.
HURRICANE MEDICAL INC
7517
In Commercial Distribution

  • 10813465011682 ()
  • 00813465011685 ()

  • Length: 33 Millimeter
  • Needle Gauge: 20 Gauge
7517

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use

PCRopsis - B550227610000

PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B550227610000 ()
22761000

  • Red blood cell separation reagent

PCRopsis - B55022761000

PCRopsis™ BCS Nano (100 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B55022761000 ()
2276100

  • Red blood cell separation reagent

PCRopsis - B55022760100

PCRopsis™ BCS Nano (10 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B55022760100 ()
2276010

  • Red blood cell separation reagent

ISSA 4 Baby - 07350120793072

ISSA 4 Baby is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Kiwi Green
In Commercial Distribution

  • 07350120793072 ()


  • Basic electric toothbrush
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