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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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Acrylic Spheres 20 mm, 3.6 cc - M8721132001

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
11-320
Not in Commercial Distribution

  • M8721132001 ()

  • Total Volume: 3.6 Milliliter
  • Outer Diameter: 20 Millimeter


  • Orbital sphere implant

Silicone Spheres (20 mm, 4.2 cc) - M8721122000

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
11-220
Not in Commercial Distribution

  • M8721122000 ()

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


  • Orbital sphere implant

Diagnostic Medical - G373DM20200

20 x 20 mm Loop
Zinnanti Surgical Design Group Inc
DM2020
In Commercial Distribution

  • G373DM20200 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use

SMMS - D830SW2020

STERILIZATION WRAP 20" X 20"
AMD Medicom Inc
SW2020
Not in Commercial Distribution

  • D830SW20201 ()
  • D830SW2020 ()


  • Sterilization packaging, single-use

EndoCurette - H671CUR1200

Endometrial Suction Curette with Syringe
UTAH MEDICAL PRODUCTS, INC.
Clear
In Commercial Distribution

  • H671CUR1201 ()
  • H671CUR1200 ()

  • Syringe Volume - 20 cc
  • Length: 27 Centimeter
  • Outer Diameter: 3.1 Millimeter
CUR-120

  • Endometrial biopsy curette

OPT CROUTONS - M505650220S0

Phosphocalcic ceramic
KASIOS
65-0220-S
In Commercial Distribution

  • M505650220S0 ()

  • 2-3 mm – 20 cc


  • Synthetic bone graft

Quala - D023Q6023351

Quala CSR Wrap 20 X 20
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Q602335
In Commercial Distribution

  • D023Q6023353 ()
  • D023Q6023351 ()
Q602335

  • Sterilization packaging, single-use

Henry Schein - H65890015861

20/20 Dentin/Enamel Light-Curing Bond
HENRY SCHEIN, INC.
9001586
In Commercial Distribution

  • H65890015861 ()
  • H65890015868 ()
9001586

  • Light-cured dental restorative composite resin

Henry Schein - H65890010200

20/20 Light Curing Hybrid Composite
HENRY SCHEIN, INC.
9001020
In Commercial Distribution

  • H65890010200 ()
9001020

  • Light-cured dental restorative composite resin

Health-Tec Sterilization Wrap - D773590100111

Health-Tec Sterilization Wrap 20" X 20"
Dental Health Products Inc
590-10011
In Commercial Distribution

  • D773590100111 ()
  • D773590100110 ()
  • D773590100115 ()

  • Area/Surface Area: 20 Square inch
590-10011

  • Sterilization packaging, single-use
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