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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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IdentiTi - 00811801039331

C-C Angled ALIF TRIAL, 5 x 38 x 28 mm, 15°
ALPHATEC SPINE, INC.
CI-10479-05382815
In Commercial Distribution

  • 00811801039331 ()

  • Depth: 28 Millimeter
  • Angle: 15 degree
  • Width: 38 Millimeter
  • Height: 5 Millimeter


  • Spinal implant trial

IdentiTi - 00811801039324

C-C Angled ALIF TRIAL, 5 x 38 x 28 mm, 10°
ALPHATEC SPINE, INC.
CI-10479-05382810
In Commercial Distribution

  • 00811801039324 ()

  • Depth: 28 Millimeter
  • Height: 5 Millimeter
  • Width: 38 Millimeter
  • Angle: 10 degree


  • Spinal implant trial

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

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 - 10697660000364

Acrylic 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 ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-322
Not in Commercial Distribution


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


  • Orbital sphere implant

Acrylic Spheres 20 mm, 3.6 cc - 10697660000357

Acrylic 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 ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-320
Not in Commercial Distribution


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


  • Orbital sphere implant

Acrylic Spheres 18 mm, 2.8 cc - 10697660000340

Acrylic 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 ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-318
Not in Commercial Distribution


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


  • Orbital sphere implant

Acrylic Spheres 16 mm, 2.1 cc - 10697660000333

Acrylic 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 ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-316
Not in Commercial Distribution


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


  • Orbital sphere implant

Acrylic Spheres 14 mm, 1.5 cc - 10697660000326

Acrylic 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 ophthalmic surgeon chooses the size and the type of implant for the surgery.
Oculo-Plastik Inc
11-314
Not in Commercial Distribution


  • Outer Diameter: 14 Millimeter
  • Total Volume: 1.5 Milliliter


  • Orbital sphere implant
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