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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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MICRO MIST NEB W/ELONG PED MASK,TBG & UN
TELEFLEX INCORPORATED
IPN049813
In Commercial Distribution

  • 24026704661323 ()
  • 14026704661326 ()
1946

  • Benchtop nebulizer, non-heated
MICRO MIST NEB W/ELONG PED MASK,TBG & UN
TELEFLEX INCORPORATED
IPN914792
In Commercial Distribution

  • 24026704670929 ()
  • 14026704670922 ()
1946

  • Benchtop nebulizer, non-heated
MICRO MIST NEB W/ELONG PED MASK,TBG & UN
TELEFLEX INCORPORATED
IPN043778
In Commercial Distribution

  • 24026704580365 ()
  • 04026704580361 ()
1946

  • Benchtop nebulizer, non-heated
GEN4 Direct Access
CURBELL MEDICAL PRODUCTS, INC.
4C360N-Z003008
In Commercial Distribution

  • 00840828107273 ()
1946

  • Pillow speaker
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


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


  • 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


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


  • Orbital sphere implant
ABSORBENT POINTS (200/box) Type: ISO, Size: 20; For more information: https://www.scottsdental.com/catalog/product/view/id/23513/s/absorbent-points-scott-s-select/
SCOTT'S DENTAL SUPPLY L.L.C.
103-9063
In Commercial Distribution

  • D77810390630 ()
  • D77810390631 ()
103-9063

  • Endodontic paper point
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
nextaro® v, 20/20 (with 5 µm filter)
sfm medical devices GmbH
20040
In Commercial Distribution

  • 04063574200401 ()


  • Medication transfer set
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