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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
Cavity set of sizes 0.1, 0.5, 2 and 4 cc for Madsen Otoflex 100
Natus Medical Denmark ApS
1012 OTOflex Cavity set
In Commercial Distribution

  • 05713315009013 ()
8-67-41300

  • Impedance audiometer
resorbable porous calcium phosphate bone void filler 25 x 100 x 8mm; 20 cc
Pioneer Surgical Technology, Inc.
90-400-251008
Not in Commercial Distribution

  • 00846468087128 ()
90-400-251008

  • Bone matrix implant, composite
resorbable porous calcium phosphate bone void filler 25 x 50 x 8mm; 10 cc
Pioneer Surgical Technology, Inc.
90-400-25508
Not in Commercial Distribution

  • 00846468087111 ()
90-400-25508

  • Bone matrix implant, composite
resorbable porous calcium phosphate bone void filler 25 x 50 x 4mm; 5 cc
Pioneer Surgical Technology, Inc.
90-400-25504
Not in Commercial Distribution

  • 00846468087104 ()
90-400-25504

  • Bone matrix implant, composite
USA Elite System Cystourethroscope Albarran Deflecting Bridge, Single-Horn 23-25 Fr, (7.7-8.3mm) CC Yellow/Green
Gyrus ACMI, LLC
E155
In Commercial Distribution

  • 00821925003286 ()


  • Rigid optical cystourethroscope
OR GWN ULT COMPEL NEGA BL XL - CC TT BL/WHT SFTY STCH CONST
STANDARD TEXTILE CO., INC.
75656694
In Commercial Distribution

  • 00634916003796 ()
  • 10634916003796 ()
75656694

  • Surgical gown, reusable
HYDROGEL COATED LATEX FOLEY INSERTION TRAY, 18 FR (6.0 MM), 5 CC, PREP TRAY
Cardinal Health 200, LLC
3044
In Commercial Distribution

  • 50192253027776 ()
  • 10192253027778 ()

  • Total Volume: 5 Milliliter
  • Catheter Gauge: 18 French
3044-

  • Indwelling urethral catheterization kit, adult
SILICONE ELASTOMER COATED LATEX T.U.R.P FOLEY CATHETER, 30-50 CC, 2-WAY, 22 FR (7.3 MM)
Cardinal Health 200, LLC
8887648221
In Commercial Distribution

  • 20192253027614 ()
  • 10192253027617 ()
  • 50192253027615 ()

  • Catheter Gauge: 22 French
8887648221-

  • Indwelling urethral drainage balloon catheter, non-antimicrobial
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