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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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Integra Peritoneal Open-Ended Catheter With Slits PERITONEAL CATHETER, 90CM LENGTH 12 mm H2O at a flow rate of 23 ml/hr.
Integra Lifesciences Corporation
NL98003S01
In Commercial Distribution

  • 10381780072546 ()
  • M269NL98003S011 ()

  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 90 cm (35 1/2") (All dimensions nominal)
NL98003S01

  • Peritoneal/atrial cerebrospinal fluid catheter
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
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
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
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
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™ 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™ 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
The Neotech Bridge is a breastfeeding assistance device intended to deliver supplemental nutrition to an infant latched at the breast/chest
Neotech Products LLC
Bridge Only - 30pcs
In Commercial Distribution

  • 00812594012600 ()
  • 20812594012604 ()
N8001-30

  • Breast pump support kit, reusable
The Oxygen Demand Valve provides 100% oxygen to patients suffering from respiratory distress at the flow rate demanded by the patient.
O-Two Medical Technologies Inc
01DV3000
In Commercial Distribution

  • 07540195020115 ()
  • 07540195020122 ()

  • Weight: 0.20 Kilogram
  • Height: 3.1 Inch
  • Outer Diameter: 2.0 Inch
01DV3000

  • Demand valve
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
ISSA 4 Baby is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Pearl Pink
In Commercial Distribution

  • 07350120793058 ()


  • Basic electric toothbrush
ISSA 4 Smile is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Summer Sky
In Commercial Distribution

  • 07350120793034 ()


  • Basic electric toothbrush
ISSA 4 Plus is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Lavender
In Commercial Distribution

  • 07350120792983 ()


  • Basic electric toothbrush
ISSA 4 Baby is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Bubble Blue
In Commercial Distribution

  • 07350120793065 ()


  • Basic electric toothbrush
ISSA 4 Smile is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Enchanted Violet
In Commercial Distribution

  • 07350120793041 ()


  • Basic electric toothbrush
ISSA 4 Smile is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Wild Strawberry
In Commercial Distribution

  • 07350120793027 ()


  • Basic electric toothbrush
ISSA 4 Plus is for use at home and to promote overall oral hygiene by cleaning your teeth and gums only.
Foreo AB
Black
In Commercial Distribution

  • 07350120792976 ()


  • Basic electric toothbrush
The i-ED COIL is used for vascular embolization with a platinum coil at the target lesion in the patient’s blood vessel.
KANEKA CORPORATION
392-0408
In Commercial Distribution

  • 04540778177031 ()

  • Complex (Soft) 10inch 4mm x 8cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
392-0408

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
Hampton Needle Holder, Curved, 9mm Jaw, With Lock, Large Knurled Round Handle, Finger Flats At Neck, Overall Length 5-1/8" (130mm)
Med Saver, Inc.
5-4937
In Commercial Distribution

  • 00194613076733 ()


  • Suturing needle holder, reusable
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