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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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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
11-216V
Not in Commercial Distribution

  • M87211216V92 ()

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


  • Orbital sphere implant
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
11-215V
Not in Commercial Distribution

  • M87211215V91 ()

  • Total Volume: 1.8 Milliliter
  • Outer Diameter: 15 Millimeter


  • Orbital sphere implant
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
11-214V
Not in Commercial Distribution

  • M87211214V90 ()

  • Total Volume: 1.4 Milliliter
  • Outer Diameter: 14 Millimeter


  • Orbital sphere implant
PRESSURE MONITORING SET
Edwards Lifesciences LLC
T440B28A
In Commercial Distribution

  • 57460691956099 ()
  • 07460691956094 ()

  • TOTAL VOLUME: 3 CC, LENGTH: 78 INCH (200 CENTIMETER)
T440B28A

  • Invasive-pressure external transducer, single-use
PRESSURE MONITORING SET
Edwards Lifesciences LLC
T434500B
In Commercial Distribution

  • 57460691949008 ()
  • 07460691949003 ()

  • Length: 8 Feet
T434500B

  • Invasive-pressure external transducer, single-use
UNIVERSAL CATHETERIZATION TRAY. CONTENTS: DRAINAGE BAG 2000 CC, SYRINGE 10 CC PRE-FILLED WITH STERILE WATER, VINYL GLOVES (1 PAIR), DRAPE, FENESTRATED DRAPE, CATHETER LUBRICATING JELLY, SPECIMEN CONTAINER 2oz, PATIENT LABEL, WRAP, PVP SWAB STICKS (3).
GHC HEALTHCARE, INC.
60-T02
In Commercial Distribution

  • 40872237001802 ()
  • 00872237001804 ()


  • Urethral catheterization support kit, urinary drainage
400mL Urine Meter attached to 2600mL Drainage Bag 100% Silicone Foley Catheter 5 cc Balloon 18 Fr.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411014691 ()
  • 10704411014690 ()
AS89818S

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use
400mL Urine Meter attached to 2600mL Drainage Bag 100% Silicone Foley Catheter 5 cc Balloon 16 Fr.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411014684 ()
  • 10704411014683 ()
AS89816S

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use
400mL Urine Meter attached to 2600mL Drainage Bag 100% Silicone Foley Catheter 5 cc Balloon 14 Fr.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411014677 ()
  • 10704411014676 ()
AS89814S

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use
400mL. Urine Meter attached to 2600mL drainage bag Hydrophilic Latex Foley Catheter 5 cc Balloon 18 Fr.
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411014660 ()
  • 10704411014669 ()
AS89818H

  • Intermittent urethral drainage catheter, non-antimicrobial, single-use
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