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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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UNO Plus 300 CC Collection Canister - 00849405000488

All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes: 200cc (Ref#: UP-S00D2) 300cc (Ref#: UP-S00D3) Each canister is individually packaged in a medical grade Tyvek pouch (1073B Tyvek and a polyester/polyethylene laminate with a 0.375” side and chevron seals). The canister is sterilized using EO sterilization method and has a shelf life of 3 years.
GENADYNE BIOTECHNOLOGIES INC.
UP-S00D3
In Commercial Distribution

  • 00849405000488 ()


  • Negative-pressure wound therapy system canister

UNO Plus 200 CC Collection Canister - 00849405000389

All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes: 200cc (Ref#: UP-S00D2) 300cc (Ref#: UP-S00D3) Each canister is individually packaged in a medical grade Tyvek pouch (1073B Tyvek and a polyester/polyethylene laminate with a 0.375” side and chevron seals). The canister is sterilized using EO sterilization method and has a shelf life of 3 years.
GENADYNE BIOTECHNOLOGIES INC.
UP-S00D2
In Commercial Distribution

  • 00849405000389 ()


  • Negative-pressure wound therapy system canister

Arthrex Calcium Sulfate BioBeads, 20 cc - 00850018568180

BONE VOID FILLER
DIMENSIONAL BIOCERAMICS LLC
ABS-3000-20
In Commercial Distribution

  • 00850018568180 ()

  • Total Volume: 20 Milliliter
ABS-3000-20

  • Bone matrix implant, synthetic, non-antimicrobial

Arthrex Calcium Sulfate BioBeads, 10 cc - 00850018568098

BONE VOID FILLER
DIMENSIONAL BIOCERAMICS LLC
ABS-3000-10
In Commercial Distribution

  • 00850018568098 ()

  • Total Volume: 10 Milliliter
ABS-3000-10

  • Bone matrix implant, synthetic, non-antimicrobial

Arthrex Calcium Sulfate BioBeads, 5 cc - 00850018568081

BONE VOID FILLER
DIMENSIONAL BIOCERAMICS LLC
ABS-3000-05
In Commercial Distribution

  • 00850018568081 ()

  • Total Volume: 5 Milliliter
ABS-3000-05

  • Bone matrix implant, synthetic, non-antimicrobial

Grid biopsy unit: lateral, medial, cc - 04251269201899

No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269201899 ()
111252

  • MRI system coil, radio-frequency

Acrylic Spheres 22 mm, 5.7 cc - M8721132203

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
11-322
Not in Commercial Distribution

  • M8721132203 ()

  • Total Volume: 5.7 Milliliter
  • Outer Diameter: 22 Millimeter


  • Orbital sphere implant

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

Acrylic Spheres 18 mm, 2.8 cc - M8721131808

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
11-318
Not in Commercial Distribution

  • M8721131808 ()

  • Total Volume: 2.8 Milliliter
  • Outer Diameter: 18 Millimeter


  • Orbital sphere implant

Acrylic Spheres 16 mm, 2.1 cc - M8721131606

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
11-316
Not in Commercial Distribution

  • M8721131606 ()

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


  • Orbital sphere implant
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