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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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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
390-01H2
In Commercial Distribution

  • 04540778176461 ()

  • Complex (Silky Soft) 10inch 1.5mm x 2cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-01H2

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
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
390-0103
In Commercial Distribution

  • 04540778176447 ()

  • Complex (Silky Soft) 10inch 1mm x 3cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0103

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
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
390-0102
In Commercial Distribution

  • 04540778176430 ()

  • Complex (Silky Soft) 10inch 1mm x 2cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0102

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
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
390-0101
In Commercial Distribution

  • 04540778176423 ()

  • Complex (Silky Soft) 10inch 1mm x 1cm
  • Compatible Microcatheter inner diameter: 0.33 to 0.48 Millimeter
390-0101

  • Non-neurovascular embolization coil
  • Neurovascular embolization coil
St Mark's Deep Retractor, 9" blade angled 15° at tip, narrow with lip, fiberoptic, Doyen handle, narrow version tapers to 3.5cm
Avalign Technologies, Inc.
63-G6110FO
In Commercial Distribution

  • 00190776384784 ()


  • Hand-held surgical retractor, reusable
V. Mueller WEINGARTNER EAR FORCEPS HAWKBILL GRASP JAW, ALLIGATOR TYPE, SERR AT DISTAL END WORKING LENGTH 3-1/8 inches 8 CM
STERIS CORPORATION
AU6190
In Commercial Distribution

  • 10885403008832 ()
AU6190

  • Surgical soft-tissue manipulation forceps, alligator, reusable
V. Mueller MCCABE MEASURING INSTRUMENT SLIGHTLY CURVED ROUND SHAFT withCALIBRATIONS AT 3, 4 and 5MM OVERALL LENGTH 6-1/8 inches 15.6CM
STERIS CORPORATION
AU12830
In Commercial Distribution

  • 10885403010156 ()
AU12830

  • Nasal depth gauge, 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
Bubble Blue
In Commercial Distribution

  • 07350120793065 ()


  • 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
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
Summer Sky
In Commercial Distribution

  • 07350120793034 ()


  • 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
Lavender
In Commercial Distribution

  • 07350120792983 ()


  • 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
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
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
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
M-Style Straight Bipolar Forcep 6 3/4" (171.45mm) With A With A 0.2mm Tip With Stop (*** PRODUCT MAY SCISSOR AT TIPS ***)
TITAN MANUFACTURING INC
163210131000101
In Commercial Distribution

  • 00817914021287 ()

  • Length: 171.45 Millimeter


  • Open-surgery electrosurgical handpiece/electrode, bipolar, 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
Kit – Bridge with Extension and 20ML & 60ML Syringes
In Commercial Distribution

  • 00812594013478 ()
N8001-Kit

  • Breast pump support kit, reusable
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
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
TTI-McPherson Tying Forceps Angled 10.5mm at 45 Degree, with 10mm Smooth Tying Platform, Round Knurled Handle, 105mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2443
In Commercial Distribution

  • G412PH24430 ()


  • Ophthalmic surgical device handling forceps, reusable
Bechert-McPherson Tying Forceps Angled 10.5mm at 45 Degree, with 10mm Smooth Tying Platform, Serrated Flat Handle, 84mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH2032
In Commercial Distribution

  • G412PH20320 ()


  • Ophthalmic surgical device handling forceps, reusable
Colibri Utility Forceps Very Delicate 1x2 Teeth set at 45 Degree, .12mm, Oval Hole Flat Handle, 75mm Overall Length, Stainless Steel
Crestpoint Management Limited
PH1028
In Commercial Distribution

  • G412PH10280 ()


  • Ophthalmic surgical device handling forceps, reusable
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