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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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Bone Graft Putty Mineral Collagen Composite
Prismatik Dentalcraft, Inc
70-BIO-BGP20
In Commercial Distribution

  • D74570BIOBGP200 ()

  • Volume, 2.0 cc
70-BIO-BGP20

  • Dental bone matrix implant, synthetic
Bone Graft Putty Mineral Collagen Composite
Prismatik Dentalcraft, Inc
70-BIO-BGP10
In Commercial Distribution

  • D74570BIOBGP100 ()

  • Volume, 1.0 cc
70-BIO-BGP10

  • Dental bone matrix implant, synthetic
Bone Graft Putty Mineral Collagen Composite
Prismatik Dentalcraft, Inc
70-BIO-BGP05
In Commercial Distribution

  • D74570BIOBGP050 ()

  • Volume, 0.5 cc
70-BIO-BGP05

  • Dental bone matrix implant, synthetic
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
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
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
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
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
No Description
Noras MRI products GmbH
01
In Commercial Distribution

  • 04251269201899 ()
111252

  • MRI system coil, radio-frequency
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
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