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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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The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-420
Not in Commercial Distribution

  • M8721242003 ()

  • Total Volume: 3.5 Milliliter
  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant
The Durette® ocular implant, made of clear acrylic material (PMMA), is a smooth-surface motility implant used for enucleation, evisceration, and secondary implantation. There are two 20 mm diameter models that are quasi-spherical: Model I, which has a slightly flattened smooth anterior surface (1 mm flatter vs. a sphere); and Model IV, which has four pronounced mounds (within the sphere) for optimal coupling and motility. The implants have a network of 20 interconnected tunnels (1 to 2 mm) offering the eye surgeon with 3 levels for suturing each rectus muscle, and allowing new tissue to form and integrate with surrounding tissue, while aiming to prevent migration, forward displacement and tissue stretching. They both have an off-center medial posterior elongation for added volume and better front positioning of details for coupling with ocular prostheses.
Oculo-Plastik Inc
12-120
Not in Commercial Distribution

  • M8721212000 ()

  • Total Volume: 4 Milliliter
  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant
3D Fusion™ Firm Matrix Band Special Kit: 80 Count (20) FXH100, (20) FXH175, (20) FXH200, (20) FXH300
GARRISON DENTAL SOLUTIONS, L.L.C.
FXHB03
In Commercial Distribution

  • 00810038095349 ()
FXHB03

  • Dental matrix band, single-use
nextaro® v, 20/20 (with 5 µm filter)
sfm medical devices GmbH
20040
In Commercial Distribution

  • 04063574200401 ()


  • Medication transfer set
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
BLUNT BLADE, 20 x 20 MM, TEAL, PINNED
TEDAN SURGICAL INNOVATIONS, L.L.C.
CS-4028-P
In Commercial Distribution

  • 00843059122275 ()


  • Surgical retractor/retraction system blade, reusable
rematitan® “LITE”, lower, narrow, 20 x 20
DENTAURUM GmbH & Co.KG
768-119-00
In Commercial Distribution

  • J011768119000 ()
  • J011768119001 ()


  • Orthodontic archwire
rematitan® “LITE”, upper, narrow, 20 x 20
DENTAURUM GmbH & Co.KG
768-118-00
In Commercial Distribution

  • J011768118000 ()
  • J011768118001 ()


  • Orthodontic archwire
Caries Detector Tip (20 Gauge) Refill, 20/Pkg
PATTERSON DENTAL SUPPLY, INC.
070842500
In Commercial Distribution

  • D6620708425002 ()


  • Syringe tip cap
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
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