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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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Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00022S
In Commercial Distribution

  • 00854066006038 ()

  • Outer Diameter: 22 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant
Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00020S
In Commercial Distribution

  • 00854066006021 ()

  • Outer Diameter: 20 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant
Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00018S
In Commercial Distribution

  • 00854066006014 ()

  • Outer Diameter: 18 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant
Hydroxyapatite (HA) Orbital Implant & Conformer used for enucleations and eviscerations.
INTEGRATED ORBITAL IMPLANTS INC
I00016S
In Commercial Distribution

  • 00854066006007 ()

  • Outer Diameter: 16 Millimeter


  • Ophthalmic conformer
  • Orbital sphere implant
eXact Suture, 3-0 PDO
Cypris Medical, Inc.
CM7430
In Commercial Distribution

  • 00854037007125 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
eXact Suture, 4-0 PDO
Cypris Medical, Inc.
CM7440
In Commercial Distribution

  • 00854037007101 ()


  • Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Disposable, single use, surgical Irrigation and Aspiration tubing set
NEOMEDIX CORPORATION
550034-01
In Commercial Distribution

  • 00854028002108 ()


  • Surgical irrigation/aspiration tubing set
DermaQuik Sport & Extreme, OTC, Enhanced Adhesive. 3 Packages in waterproof pouch. Each package contains 1 DermaQuik device which will close 1" of wound.
Dermaclip Us, L.L.C.
Sport & Extreme 3 Multi-pouch
In Commercial Distribution

  • 00853909006525 ()
  • 00853909006297 ()

  • Width: 21 Millimeter
62532

  • Skin-closure adhesive strip
DermaQuik Home & Field, OTC, Standard Adhesive. 3 Packages in waterproof pouch. Each package contains 1 DermaQuik device which will close 1" of wound.
Dermaclip Us, L.L.C.
Home & Field 3 Multi-pouch
In Commercial Distribution

  • 00853909006518 ()
  • 00853909006280 ()

  • Width: 21 Millimeter
62531

  • Skin-closure adhesive strip
DermaQuik Sport & Extreme Wound Closure Kit, OTC. Waterproof kit includes 2 Packages of DermaQuik Sport & Extreme Devices (1 Clip per Package, 1" Closure per Package), Enhanced Adhesive. Kit also includes 2 gauze pads, 2 alcohol swabs, 2 wound dressings. All products are packaged individually within the kit and are sterile.
Dermaclip Us, L.L.C.
Sport & Extreme Wound Closure Kit
In Commercial Distribution

  • 00853909006495 ()
  • 00853909006365 ()
  • 00853909006297 ()

  • Width: 21 Millimeter
62552

  • Skin-closure adhesive strip
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