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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 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
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
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
No Description
Dynarex Corporation
32262
In Commercial Distribution

  • 00840117321601 ()
  • 00840117321540 ()


  • Suction system canister liner
No Description
Dynarex Corporation
32261
In Commercial Distribution

  • 00840117321595 ()
  • 00840117321533 ()


  • Suction system canister liner
No Description
Dynarex Corporation
32260
In Commercial Distribution

  • 00840117321588 ()
  • 00840117321526 ()


  • Suction system canister liner
No Description
PARKS MEDICAL ELECTRONICS, INC.
811-B 24V 800CC
In Commercial Distribution

  • 00816787020236 ()


  • Laser Doppler blood flowmeter
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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