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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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16 in. (38 cm) Q2 Checkmate extension set - 00634624954809

No Description
QUEST MEDICAL INC
9548
In Commercial Distribution

  • 20634624954803 ()
  • 00634624954809 ()
9548

  • Intravenous administration tubing extension set

10 in. (25 cm) Q2 Checkmate extension set - 00634624095458

No Description
QUEST MEDICAL INC
9545
In Commercial Distribution

  • 00634624095458 ()
9545

  • Intravenous administration tubing extension set

ADAPTOR,1,P808,S808,1/4"N,IN,TT - 00840828118804

ADAPTOR,1,P808,S808,1/4"N,IN,TT
CURBELL MEDICAL PRODUCTS, INC.
ADP-0808-101
In Commercial Distribution

  • 00840828118804 ()
3322

  • Electrical mains power extension cable

Straight In/Bifurcated Out Pt Line (1 Piece) - 00896128002152

No Description
BELMONT INSTRUMENT CORPORATION
902-00040P
In Commercial Distribution

  • 00896128002152 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal

Hyperthermia Pump St In/Bifurcated Out Pt Line - 00896128002244

No Description
BELMONT INSTRUMENT CORPORATION
902-00009P
Not in Commercial Distribution

  • 00896128002244 ()


  • Extravascular-circulation hyperthermia system applicator, intracorporeal

Bilateral Conformer 22 Regular With Holes, In Bulk - M87219094TV90

Conformers (made of acrylic or PMMA) are single use devices. They are used to keep the form of the orbital cavity after enucleation or evisceration. In fact, a well chosen conformer enhances healing and prevents retraction of the cul-de-sac. It facilitates the fabrication and the retention of the ocular prosthesis. The conformer temporarily takes the place of the volume lost after enucleation or evisceration and keeps the lids in their natural position. It can be inserted in both eyes (left eye or right eye). The conformer is inserted behind the lids at the end of the surgery and stays in place until the next appointment with the ophthalmologist and/or the ocularist before an ocular prosthesis is made. This period of time varies for each patient and can range between one (1) to four (4) weeks. The conformer is never worn for more than 30 days continuously.
Oculo-Plastik Inc
19-094TV
Not in Commercial Distribution

  • M87219094TV90 ()

  • Depth: 1.8 Millimeter
  • Width: 23 Millimeter
  • Length: 28 Millimeter


  • Ophthalmic conformer

Silicone Spheres (22 mm, 5.6 cc) In Bulk - M87211222V9

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
11-222V
Not in Commercial Distribution

  • M87211222V9 ()

  • Total Volume: 5.6 Milliliter
  • Outer Diameter: 22 Millimeter


  • Orbital sphere implant

Silicone Spheres (21 mm, 4.8 cc) In Bulk - M87211221V9

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
11-221V
Not in Commercial Distribution

  • M87211221V9 ()

  • Outer Diameter: 21 Millimeter
  • Total Volume: 4.8 Milliliter


  • Orbital sphere implant

Silicone Spheres (20 mm, 4.2 cc) In Bulk - M87211220V9

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
11-220V
Not in Commercial Distribution

  • M87211220V9 ()

  • Outer Diameter: 20 Millimeter
  • Total Volume: 4.2 Milliliter


  • Orbital sphere implant

Silicone Spheres (19 mm, 3.6 cc) In Bulk - M87211219V95

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
11-219V
Not in Commercial Distribution

  • M87211219V95 ()

  • Total Volume: 3.6 Milliliter
  • Outer Diameter: 19 Millimeter


  • Orbital sphere implant
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