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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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Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Mini 290 cc
Establishment Labs S.A.
RSM-290+
In Commercial Distribution

  • 07445161001733 ()
RSM-290+

  • Silicone gel-filled breast implant, smooth-surface
Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Mini 275 cc
Establishment Labs S.A.
RSM-275+
In Commercial Distribution

  • 07445161001726 ()
RSM-275+

  • Silicone gel-filled breast implant, smooth-surface
Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Mini 260 cc
Establishment Labs S.A.
RSM-260+
In Commercial Distribution

  • 07445161001719 ()
RSM-260+

  • Silicone gel-filled breast implant, smooth-surface
Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Mini 245 cc
Establishment Labs S.A.
RSM-245+
In Commercial Distribution

  • 07445161001702 ()
RSM-245+

  • Silicone gel-filled breast implant, smooth-surface
Lab Screw Implant Level CC RP/WP and Ext Hex RP 5/pkg
Nobel Biocare AB
37895
In Commercial Distribution

  • 07332747150292 ()
  • 07332747212303 ()
37895

  • Dental implant suprastructure, temporary, preformed, reusable
Lab Screw Implant Level CC RP/WP and Ext Hex RP 5/pkg
Nobel Biocare AB
37895
In Commercial Distribution

  • 17332747007104 ()
  • 07332747150292 ()
37895

  • Dental implant suprastructure, temporary, preformed, reusable
Manual - Ratchet - Fix Key for Implant - Extra Extra Long L.25 mm. - CC
FAICO MEDICAL LLC
AST00250APCRC
Not in Commercial Distribution

  • 00840192716408 ()


  • Dental implant system
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
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
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