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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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Gateway® - 08714729791287

PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
M0032072209400
In Commercial Distribution

  • 08714729791287 ()

  • 9 mm Length
  • 4.0 mm Diameter
M0032072209400

  • Peripheral angioplasty balloon catheter, basic

Gateway® - 08714729791256

PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
M0032072220300
In Commercial Distribution

  • 08714729791256 ()

  • 3.0 mm Diameter
  • 20 mm Length
M0032072220300

  • Peripheral angioplasty balloon catheter, basic

Gateway® - 08714729807247

PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
M0032072220370
In Commercial Distribution

  • 08714729807247 ()

  • 20 mm Length
  • 3.75 mm Diameter
M0032072220370

  • Peripheral angioplasty balloon catheter, basic

Gateway® - 08714729807230

PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
M0032072220350
In Commercial Distribution

  • 08714729807230 ()

  • 3.5 mm Diameter
  • 20 mm Length
M0032072220350

  • Peripheral angioplasty balloon catheter, basic

MESOMARK - 00869164000000

No Description
Fujirebio Diagnostics, Inc.
801-905
Not in Commercial Distribution

  • 00869164000000 ()

  • Size Type = Tests Per Kit; Size Unit = 96; Unit of Measure = Tests


  • Mucin-like carcinoma-associated antigen (MCA) IVD, kit, enzyme immunoassay (EIA)

NeVa VS - Vessel Dilation Device - 00851279008767

Temporary percutaneous transluminal cerebral artery dilation device.
Vesalio
VS-4022-F1RR
In Commercial Distribution

  • 00851279008767 ()
VS-4022-F1RR

  • Thrombectomy suction catheter

Argus II Retinal Prosthesis Retinal Tacks - 10856264005322

The Argus II Retinal Tack is used to affix the electrode array of the Retinal Prosthesis to the retina.
Second Sight Medical Products, Inc.
011006-001
Not in Commercial Distribution

  • 10856264005322 ()
  • 00856264005325 ()
011006

  • Retinal tack

Argus ll Operating Room Coil - 00856264005387

The operating room coil is used during surgery in replacement of the glasses. A telemetry coil and radio-frequency system are mounted on the device to provide communication between the implant and the VPU during surgery.
Second Sight Medical Products, Inc.
012103-003
Not in Commercial Distribution

  • 00856264005387 ()
012103

  • Retinal prosthesis system implantation test coil

PyroCarbon PIP Total Joint System - 00885556858400

PIP SZ. 10 PROXIMAL
Smith & Nephew, Inc.
PIP-200-10P-WW
In Commercial Distribution

  • 00885556858400 ()
PIP-200-10P-WW

  • Surgical soft-tissue manipulation forceps, alligator, reusable

Elana Surgical Kit HUD - M602801H00013

Elana Surical Kit HUD The Elana Sutrgical Kit HUD contains: The Elana Laser Catheter 2.0, The Elana Rings 2.6&2.8 and a vacuum extension tube. The Elana Surgical Kit HUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.
Elana B.V.
1
In Commercial Distribution

  • M602801H00013 ()
801-H.00.01

  • Vascular-grafting anastomosis system
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