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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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Pediatric Laparotomy Drape II with Armboard Covers
O&M HALYARD, INC.
48076
In Commercial Distribution

  • 30680651480768 ()
  • 10680651480764 ()
48076

  • Cardiac mapping system application software
Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging.
SALIENT IMAGING
1.2
In Commercial Distribution

  • B725INITVV1 ()
  • B725INITVV12 ()
INITVV

  • Ultrasound imaging system application software
8.5 MM GRAFT SIZING TUBE
Smith & Nephew, Inc.
7207165
In Commercial Distribution

  • 03596010253330 ()
7207165

  • Ligament graft sizer, noninvasive
TUBE SIZING 7.5MM
Smith & Nephew, Inc.
7207164
In Commercial Distribution

  • 03596010253323 ()
7207164

  • Ligament graft sizer, noninvasive
6.5 MM GRAFT SIZING TUBE
Smith & Nephew, Inc.
7207163
In Commercial Distribution

  • 03596010253316 ()
7207163

  • Ligament graft sizer, noninvasive
Vascular documentation software
KOVEN TECHNOLOGY, INC.
Smart-V-Link
In Commercial Distribution

  • 00894912002777 ()
Smart-V-Link

  • Ultrasound imaging system application software
The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for: - Endoanal ultrasound (trans-rectal ultrasound / echography) - Anoscopy exams - Manometry exams
THD SPA
THD Procto Software
In Commercial Distribution

  • 08033737713037 ()
760004

  • Ultrasound imaging system application software
The Triad Combination Unit is a programmable advanced digital signal processing system incorporating Tinnitus noise masking for patients that suffer from hearing loss, hyperacusis, and or Tinnitus.
GENERAL HEARING INSTRUMENT, INC.
Triad Combo,OTE,10A,Digital,Polytube,Grey,Pair
In Commercial Distribution

  • 00089518000740 ()


  • Air-conduction tinnitus masker, out-of-ear
The Triad Combination Unit is a programmable advanced digital signal processing system incorporating Tinnitus noise masking for patients that suffer from hearing loss, hyperacusis, and or Tinnitus.
GENERAL HEARING INSTRUMENT, INC.
Triad Combo,OTE,10A,Digital,Polytube,Grey,Right
In Commercial Distribution

  • 00089518000733 ()


  • Air-conduction tinnitus masker, out-of-ear
The Triad Combination Unit is a programmable advanced digital signal processing system incorporating Tinnitus noise masking for patients that suffer from hearing loss, hyperacusis, and or Tinnitus.
GENERAL HEARING INSTRUMENT, INC.
Triad Combo,OTE,10A,Digital,Polytube,Grey,Left
In Commercial Distribution

  • 00089518000726 ()


  • Air-conduction tinnitus masker, out-of-ear
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