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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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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
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
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 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
Thrombinator™ System
ARTHREX, INC.
ABS-10080
In Commercial Distribution

  • 00888867286580 ()
ABS-10080

  • Haematological concentrate system preparation kit, thrombin separation
RF Filter Module For CLEARSIGN™ Amplifier
BOSTON SCIENTIFIC CORPORATION
M00420012300
In Commercial Distribution

  • 08714729882961 ()


  • Electronic signal frequency filter
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