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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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Venos Occlusion Balloon Catheter - 00836559006916

Occlusion Balloon Catheter, 5F
Oscor Inc.
V0510010
Not in Commercial Distribution

  • 00836559006916 ()

  • Length: 100 Centimeter
  • Balloon Diameter 10 mm
  • Outer Diameter: 1.7 Millimeter
  • Required Syringe Size 0.75 cc
V0510010

  • Cardiac sizing catheter

Novo Surgical Inc. - 00842331149269

graduated measuring cup, stainless steel, easy-grip handles, large, smooth pouring spout, graduated in oz. & cc on the interior surface, 16 oz., 3 3/4" x 4 5/8"
NOVO SURGICAL, INC.
9595-16
In Commercial Distribution

  • 00842331149269 ()
9595-16

  • Sponge bowl, reusable

Novo Surgical Inc. - 00842331128219

graduated measuring cup, stainless steel, easy-grip handles, large, smooth pouring spout, graduated in oz. & cc on the interior surface, 32 oz., 4 3/4" x 5 1/4"
NOVO SURGICAL, INC.
9595-32
In Commercial Distribution

  • 00842331128219 ()
9595-32

  • Sponge bowl, reusable

LINEUM OCT SPINE SYSTEM - 00888480609247

No Description
BIOMET SPINE LLC
14-524506
In Commercial Distribution

  • 00888480609247 ()

  • LINEUM 4.0MM X 6MM CC SCREW TRANSLATING SCREW LINEUM OCT SPINE SYSTEM
14-524506

  • Bone-screw internal spinal fixation system, non-sterile

inFlow Intraurethral Valve-Pump - 08625630003027

Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump

Trigon - 00810005669368

Trigon CC Wedge Case Assembly. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001C-300
In Commercial Distribution

  • 00810005669368 ()


  • Surgical instrument/implant rack

Trigon - 00810005669436

Trigon CC Wedge Case Assembly. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CC-1001C-100
Not in Commercial Distribution

  • 00810005669436 ()


  • Surgical instrument/implant rack

Trigon - 00814008029785

Instrument: CC Wedge Inserter. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001T-CCI
In Commercial Distribution

  • 00814008029785 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669429

Instrument: CC Wedge 14mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2514T-CC
In Commercial Distribution

  • 00810005669429 ()

  • 14mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669399

Instrument: CC Wedge 8mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2508T-CC
In Commercial Distribution

  • 00810005669399 ()

  • 8mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable
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