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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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A sterile, implantable, single-lumen tube intended to provide tear drainage from the front surface of the eye, typically into the nasal cavity or a paranasal sinus, as a drainage treatment for lacrimal canalicular pathologies in functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent, the device may be implanted after surgery to dilate or create a surgical passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer material(s) [e.g., silicone].
FCI S A S FCI 20 22
MINI MONOKA ® FAYET & BERNARD ®
In Commercial Distribution

  • 33760087120395 ()
  • 03760087120394 ()

  • Length: 50 Millimeter
S1.1500

  • Lacrimal tube
A sterile ophthalmic lens intended to be placed on the cornea of a patient to improve visualization of the fundus and retinal structures by surgical staff using an ophthalmic microscope during vitreoretinal surgery. Also known as a vitrectomy sutureless lens (VSL), it is made of various transparent materials [e.g., polymethylmethacrylate (PMMA), glass, quartz]. This is a single-use device.
FCI S A S FCI 20 22
DISPOSABLE BICONCAVE LENS
In Commercial Distribution

  • 53760087122218 ()
  • 03760087122213 ()

  • Angle: 36 degree
S5.7040U

  • Vitrectomy contact lens, single-use
A sterile, non-bioabsorbable device intended to be implanted for intrascleral and episcleral buckling for the surgical treatment of retinal detachment. It is typically a moulded solid silicone or silicone sponge device available in a variety of shapes and sizes that is used to compress the retina long-term (up to months) to support its reattachment following the operative treatment of severe retinal detachment. This device, also known as a scleral buckling component, will occupy the intraocular space to provide compression against the retina so that it can reattach. It is typically removed after a period of time depending upon the clinical findings.
FCI S A S FCI 20 22
BICONVEX TIRE 12 TYPE 289
In Commercial Distribution

  • 53760087121433 ()
  • 03760087121438 ()

  • Width: 10 Millimeter
  • Outer Diameter: 33.2 Millimeter
  • Lumen/Inner Diameter: 25.4 Millimeter
S5.2325U

  • Scleral buckling device, non-bioabsorbable
SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.
BIOVENTUS LLC
100X25X8 MM, 20 CC
In Commercial Distribution

  • 00816986020501 ()
SGFS-020

  • Synthetic bone graft
Straight Thoracic Catheter, 20 French x 20 IN
DIVERSATEK HEALTHCARE, INC.
1240-20
In Commercial Distribution

  • M7831240201 ()
  • M7831240200 ()

  • Length: 20 Inch
  • Catheter Gauge: 20 French
1240-20

  • Pleural catheter
BluEX-A (29 X 38 X 20 mm, 20°)
L&K BIOMED CO. ,LTD.
BA2938-2020S
In Commercial Distribution

  • 08809986466051 ()


  • Metallic spinal interbody fusion cage
SurgiMend® Macroporous 20 cm x 20 cm
TEI BIOSCIENCES INC.
606-206-002
In Commercial Distribution

  • 10381780357360 ()

  • 1.75mm - 2.50mm
  • 20 cm x 20 cm
606-206-002

  • Extra-gynaecological surgical mesh, collagen, non-bioabsorbable
Step OSStaple 20 x 20 x 9 W2x3
Biomedical Enterprises, Inc.
OS-2020-09W2x3
In Commercial Distribution

  • 00810633021309 ()

  • Width: 20 Millimeter
  • Length: 20 Millimeter
  • Length: 09 Millimeter


  • Orthopaedic bone staple, non-adjustable
Step OSStaple 20 X 20 X 6 W2X3
Biomedical Enterprises, Inc.
OS-2020-06W2x3
In Commercial Distribution

  • 00810633021293 ()

  • Length: 06 Millimeter
  • Length: 20 Millimeter
  • Width: 20 Millimeter


  • Orthopaedic bone staple, non-adjustable
Step OSStaple 20 x 20 x 4 W2x3
Biomedical Enterprises, Inc.
OS-2020-04W2x3
In Commercial Distribution

  • 00810633021286 ()

  • Width: 20 Millimeter
  • Length: 20 Millimeter
  • Length: 04 Millimeter


  • Orthopaedic bone staple, non-adjustable
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