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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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Bardex® Lubri-Sil® All Silicone Lubricious Coated 5 cc Foley Catheter
C. R. Bard, Inc.
175812
In Commercial Distribution

  • 10801741034142 ()
  • 00801741034145 ()

  • Catheter Gauge: 12 French
175812

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
Touchscreen tablet computer configured with Nova-Link app for use with OtoNova Pro. Android/Windows/iPadOS as per customer requirement.
OTODYNAMICS LIMITED
NOVA-TABLET
In Commercial Distribution

  • 05060396171512 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer
Mobile app for recording breath sounds and snoring during sleep, along with file transfer from Bluetooth sleep recording devices
ENSODATA, INC.
8.0
In Commercial Distribution

  • 00864458000452 ()


  • Sleep disorder interpretive software, professional-only
A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive intended to be used as an alternative to injection for the transport of ionic-solutions medication through the movement of ions, resulting from an applied electric field to locally administer the medication transcutaneously. It typically consists of a positive and a negative electrode, a reservoir/drug chamber that holds the medication. The reservoir must be filled by the user with drug prior to use. This is a single-use device.
AXELGAARD MANUFACTURING CO., LTD.
Ionto480 DDB375
In Commercial Distribution

  • 00856817005918 ()

  • 2.0 cc fill volume
DDB375

  • Drug-delivery iontophoresis patch
A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive intended to be used as an alternative to injection for the transport of ionic-solutions medication through the movement of ions, resulting from an applied electric field to locally administer the medication transcutaneously. It typically consists of a positive and a negative electrode, a reservoir/drug chamber that holds the medication. The reservoir must be filled by the user with drug prior to use. This is a single-use device.
AXELGAARD MANUFACTURING CO., LTD.
Ionto480 DDL350
In Commercial Distribution

  • 00856817005901 ()

  • 4.0 cc fill volume
DDL350

  • Drug-delivery iontophoresis patch
A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive intended to be used as an alternative to injection for the transport of ionic-solutions medication through the movement of ions, resulting from an applied electric field to locally administer the medication transcutaneously. It typically consists of a positive and a negative electrode, a reservoir/drug chamber that holds the medication. The reservoir must be filled by the user with drug prior to use. This is a single-use device.
AXELGAARD MANUFACTURING CO., LTD.
Ionto480 DDM325
In Commercial Distribution

  • 00856817005895 ()

  • 2.5 cc fill volume
DDM325

  • Drug-delivery iontophoresis patch
A non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive intended to be used as an alternative to injection for the transport of ionic-solutions medication through the movement of ions, resulting from an applied electric field to locally administer the medication transcutaneously. It typically consists of a positive and a negative electrode, a reservoir/drug chamber that holds the medication. The reservoir must be filled by the user with drug prior to use. This is a single-use device.
AXELGAARD MANUFACTURING CO., LTD.
Ionto480 DDS275
In Commercial Distribution

  • 00856817005888 ()

  • 1.5 cc fill volume
DDS275

  • Drug-delivery iontophoresis patch
Round, smooth-surface, saline-filled breast implant.
IDEAL IMPLANT INCORPORATED
67501
In Commercial Distribution

  • 10851795006138 ()

  • Total Volume, 675 cc
675

  • Saline-filled breast implant, unstructured
Round, smooth-surface, saline-filled breast implant.
IDEAL IMPLANT INCORPORATED
63501
In Commercial Distribution

  • 10851795006121 ()

  • Total Volume, 635 cc
635

  • Saline-filled breast implant, unstructured
Round, smooth-surface, saline-filled breast implant.
IDEAL IMPLANT INCORPORATED
59501
In Commercial Distribution

  • 10851795006114 ()

  • Total Volume, 595 cc
595

  • Saline-filled breast implant, unstructured
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