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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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Silicone Spheres (20 mm, 4.2 cc) In Bulk - M87211220V9

Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-220V
Not in Commercial Distribution

  • M87211220V9 ()

  • Outer Diameter: 20 Millimeter
  • Total Volume: 4.2 Milliliter


  • Orbital sphere implant

Silicone Spheres (19 mm, 3.6 cc) In Bulk - M87211219V95

Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-219V
Not in Commercial Distribution

  • M87211219V95 ()

  • Total Volume: 3.6 Milliliter
  • Outer Diameter: 19 Millimeter


  • Orbital sphere implant

Silicone Spheres (16 mm, 2.1 cc) In Bulk - M87211216V92

Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-216V
Not in Commercial Distribution

  • M87211216V92 ()

  • Outer Diameter: 16 Millimeter
  • Total Volume: 2.1 Milliliter


  • Orbital sphere implant

Silicone Spheres (15 mm, 1.8 cc) In Bulk - M87211215V91

Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-215V
Not in Commercial Distribution

  • M87211215V91 ()

  • Total Volume: 1.8 Milliliter
  • Outer Diameter: 15 Millimeter


  • Orbital sphere implant

Silicone Spheres (14 mm, 1.4 cc) In Bulk - M87211214V90

Acrylic and silicone spheres are permanent implants used to replace the lost volume and to give motility to the ocular prosthesis following an enucleation, evisceration or an insertion of a secondary implant (to replace an implant that was or has to be removed) in ophthalmology. These ocular implants are sold non sterile. They must be sterilized before usage. The users must gas sterilize (EtO) the acrylic spheres (not autoclave). The silicone spheres can be autoclaved (steam). The ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-214V
Not in Commercial Distribution

  • M87211214V90 ()

  • Total Volume: 1.4 Milliliter
  • Outer Diameter: 14 Millimeter


  • Orbital sphere implant

OSTEOPORE TCP - M505SC44220G0

Phosphocalcic ceramic
KASIOS
SC44220G
In Commercial Distribution

  • M505SC44220G0 ()

  • 2-3 mm – 20 cc – 12,4 g


  • Synthetic bone graft

OSTEOPORE TCP - M505SC44210G0

Phosphocalcic ceramic
KASIOS
SC44210G
In Commercial Distribution

  • M505SC44210G0 ()

  • 2-3 mm – 10 cc – 6,2 g


  • Synthetic bone graft

Mini-Bowls - D701BMM22

Non-stick silicone for acrylics, with suction base. Medium, 30 cc (Set of 2) (1 5/8” diameter)
PULPDENT CORPORATION
B-MM2
In Commercial Distribution

  • D701BMM22 ()
  • D701BMM1 ()


  • Dental material mixing surface, chairside, reusable

SciPharm NewCore, Core Build-Up Restorative Automix - D801SP57013T1

NewCore - Core Build-Up Restorative Material in Automix Cartridges. 50 cc Dual Barrel Cartridge. Blue Shade. Trial Size.
SCIENTIFIC PHARMACEUTICALS, INC.
SP 57-013 T
In Commercial Distribution

  • D801SP57013T1 ()
57-013

  • Dental composite resin

Duraliner II – Nylon Fiber - D9471601N1

Denture relining material/4 OZ. POWDER / 4 OZ. LIQUID / 8.5 cc Liquid (113 GR POWDER / 118 ML LIQUID)
Reliance Dental Manufacturing Co Inc
1601-N
In Commercial Distribution

  • D9471601N1 ()


  • Dental impression tray material
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