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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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Silicone Spheres (15 mm, 1.8 cc) In Bulk - M87211215V91

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

Silicone Spheres (15 mm, 1.8 cc) - M8721121504

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
11-215
Not in Commercial Distribution

  • M8721121504 ()

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


  • Orbital sphere implant

Silicone Spheres (14 mm, 1.4 cc) In Bulk - M87211214V90

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

Silicone Spheres (14 mm , 1.4 cc) - M8721121403

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
11-214
Not in Commercial Distribution

  • M8721121403 ()

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


  • Orbital sphere implant

Silicone Spheres (12 mm, 0.9cc) In Bulk - M87211212V9

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
11-212V
Not in Commercial Distribution

  • M87211212V9 ()

  • Outer Diameter: 12 Millimeter
  • Total Volume: 0.9 Milliliter


  • Orbital sphere implant

Silicone Spheres (12 mm, 0.9 cc) - M8721121201

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
11-212
Not in Commercial Distribution

  • M8721121201 ()

  • Outer Diameter: 12 Millimeter
  • Total Volume: 0.9 Milliliter


  • Orbital sphere implant

MEDPOR - 07613252088585

MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80014
In Commercial Distribution

  • 07613252088585 ()

  • Diameter: 22.0 Millimeter
80014

  • Orbital sphere implant

MEDPOR - 07613252088578

MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80012
In Commercial Distribution

  • 07613252088578 ()

  • Diameter: 20.0 Millimeter
80012

  • Orbital sphere implant

MEDPOR - 07613252088561

MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80008
In Commercial Distribution

  • 07613252088561 ()

  • Diameter: 16.0 Millimeter
80008

  • Orbital sphere implant

MEDPOR - 07613252088424

Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6322
In Commercial Distribution

  • 07613252088424 ()

  • Diameter: 22.0 Millimeter
6322

  • Orbital sphere implant

MEDPOR - 07613252083405

Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6327
In Commercial Distribution

  • 07613252083405 ()

  • Diameter: 18.0 Millimeter
6327

  • Orbital sphere implant

MEDPOR - 07613252083399

Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6326
In Commercial Distribution

  • 07613252083399 ()

  • Diameter: 16.0 Millimeter
6326

  • Orbital sphere implant

MEDPOR - 07613252083382

Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6316
In Commercial Distribution

  • 07613252083382 ()

  • Diameter: 14.0 Millimeter
6316

  • Orbital sphere implant

MEDPOR - 07613252084044

MEDPOR¿ SST? EZ? Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
80010
In Commercial Distribution

  • 07613252084044 ()

  • Diameter: 18.0 Millimeter
80010

  • Orbital sphere implant

MEDPOR - 07613252083375

Sphere with Enucleation Implant Inserter
Stryker Leibinger GmbH & Co. KG
6317
In Commercial Distribution

  • 07613252083375 ()

  • Diameter: 20.0 Millimeter
6317

  • Orbital sphere implant

Silicone Eye Sphere - 22mm - B091143560

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14356
Not in Commercial Distribution

  • B091143560 ()

  • Outer Diameter: 22 Millimeter
14356

  • Orbital sphere implant

Silicone Eye Sphere - 20mm - B091143550

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14355
Not in Commercial Distribution

  • B091143550 ()

  • Outer Diameter: 20 Millimeter
14355

  • Orbital sphere implant

Silicone Eye Sphere - 18mm - B091143540

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14354
Not in Commercial Distribution

  • B091143540 ()

  • Outer Diameter: 18 Millimeter
14354

  • Orbital sphere implant

Silicone Eye Sphere - 16mm - B091143530

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14353
Not in Commercial Distribution

  • B091143530 ()

  • Outer Diameter: 16 Millimeter
14353

  • Orbital sphere implant

Silicone Eye Sphere - 14mm - B091143520

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14352
Not in Commercial Distribution

  • B091143520 ()

  • Outer Diameter: 14 Millimeter
14352

  • Orbital sphere implant

Silicone Eye Sphere - 12mm - B091143510

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14351
Not in Commercial Distribution

  • B091143510 ()

  • Outer Diameter: 12 Millimeter
14351

  • Orbital sphere implant

22mm Sterile Orbital Implant (PMMA) - B091142560

No Description
Gulden Ophthalmics Inc.
14256
In Commercial Distribution

  • B091142560 ()

  • Outer Diameter: 22 Millimeter
14256

  • Orbital sphere implant

20mm Sterile Orbital Implant (PMMA) - B091142550

No Description
Gulden Ophthalmics Inc.
14255
In Commercial Distribution

  • B091142550 ()

  • Outer Diameter: 20 Millimeter
14255

  • Orbital sphere implant

18mm Sterile Orbital Implant (PMMA) - B091142540

No Description
Gulden Ophthalmics Inc.
14254
In Commercial Distribution

  • B091142540 ()

  • Outer Diameter: 18 Millimeter
14254

  • Orbital sphere implant

16mm Sterile Orbital Implant (PMMA) - B091142530

No Description
Gulden Ophthalmics Inc.
14253
In Commercial Distribution

  • B091142530 ()

  • Outer Diameter: 16 Millimeter
14253

  • Orbital sphere implant

14mm Sterile Orbital Implant (PMMA) - B091142520

No Description
Gulden Ophthalmics Inc.
14252
In Commercial Distribution

  • B091142520 ()

  • Outer Diameter: 14 Millimeter
14252

  • Orbital sphere implant

12mm Sterile Orbital Implant (PMMA) - B091142510

No Description
Gulden Ophthalmics Inc.
14251
In Commercial Distribution

  • B091142510 ()

  • Outer Diameter: 12 Millimeter
14251

  • Orbital sphere implant

10mm Sterile Orbital Implant (PMMA) - B091142500

No Description
Gulden Ophthalmics Inc.
14250
In Commercial Distribution

  • B091142500 ()

  • Outer Diameter: 10 Millimeter
14250

  • Orbital sphere implant

22mm Eye Sphere (non-sterile) - B091141561

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14156
In Commercial Distribution

  • B091141561 ()
  • B091141560 ()

  • Outer Diameter: 22 Millimeter
14156

  • Orbital sphere implant

22mm Eye Sphere (non-sterile) - B091141560

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14156
In Commercial Distribution

  • B091141560 ()

  • Outer Diameter: 22 Millimeter
14156

  • Orbital sphere implant

20mm Eye Sphere (non-sterile) - B091141551

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14155
In Commercial Distribution

  • B091141551 ()
  • B091141550 ()

  • Outer Diameter: 20 Millimeter
14155

  • Orbital sphere implant

20mm Eye Sphere (non-sterile) - B091141550

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14155
In Commercial Distribution

  • B091141550 ()

  • Outer Diameter: 20 Millimeter
14155

  • Orbital sphere implant

18mm Eye Sphere (non-sterile) - B091141541

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14154
In Commercial Distribution

  • B091141541 ()
  • B091141540 ()

  • Outer Diameter: 18 Millimeter
14154

  • Orbital sphere implant

18mm Eye Sphere (non-sterile) - B091141540

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow the future use of a prosthesis.
Gulden Ophthalmics Inc.
14154
In Commercial Distribution

  • B091141540 ()

  • Outer Diameter: 18 Millimeter
14154

  • Orbital sphere implant

16mm Eye Sphere (non-sterile) - B091141531

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14153
In Commercial Distribution

  • B091141531 ()
  • B091141530 ()

  • Outer Diameter: 16 Millimeter
14153

  • Orbital sphere implant

16mm Eye Sphere (non-sterile) - B091141530

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14153
In Commercial Distribution

  • B091141530 ()

  • Outer Diameter: 16 Millimeter
14153

  • Orbital sphere implant

14mm Eye Sphere (non-sterile) - B091141521

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14152
In Commercial Distribution

  • B091141521 ()
  • B091141520 ()

  • Outer Diameter: 14 Millimeter
14152

  • Orbital sphere implant

14mm Eye Sphere (non-sterile) - B091141520

Eye Sphere is implanted to fill the eye sac during evisceration or enucleation to allow future use of a prosthesis.
Gulden Ophthalmics Inc.
14152
In Commercial Distribution

  • B091141520 ()

  • Outer Diameter: 14 Millimeter
14152

  • Orbital sphere implant

12mm Eye Sphere (non-sterile) - B091141511

Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14151
In Commercial Distribution

  • B091141511 ()
  • B091141510 ()

  • Outer Diameter: 12 Millimeter
14151

  • Orbital sphere implant

12mm Eye Sphere (non-sterile) - B091141510

Eye Sphere is implanted to fill the eye sac during enucleation or evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14151
In Commercial Distribution

  • B091141510 ()

  • Outer Diameter: 12 Millimeter
14151

  • Orbital sphere implant

10mm Eye Sphere (non-sterile) - B091141501

Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14150
In Commercial Distribution

  • B091141501 ()
  • B091141500 ()

  • Outer Diameter: 10 Millimeter
14150

  • Orbital sphere implant

10mm Eye Sphere (non-sterile) - B091141500

Eye Sphere is implanted to fill the volume of the eye sac in enucleation and evisceration surgery to enable future use of a prosthesis.
Gulden Ophthalmics Inc.
14150
In Commercial Distribution

  • B091141500 ()

  • Outer Diameter: 10 Millimeter
14150

  • Orbital sphere implant

MEDPOR - 07613252170297

Malar Implant Teardrop Standard
Stryker Leibinger GmbH & Co. KG
6323
In Commercial Distribution

  • 07613252170297 ()

  • Length: 30.0 Millimeter
  • Diameter: 5.6 Millimeter
6323

  • Orbital sphere implant

IMS - 10889950067175

8x10.5 16 INST Q CASSETTE, OCEAN BLUE
HU-FRIEDY MFG. CO., LLC
IMN41611Q
Not in Commercial Distribution

  • 10889950067175 ()
IMN41611Q

  • Device sterilization/disinfection container, reusable

IMS - 10889950066840

8X10.5 12 INST Q CASSETTE, OCEAN BLUE
HU-FRIEDY MFG. CO., LLC
IMN41211Q
Not in Commercial Distribution

  • 10889950066840 ()
IMN41211Q

  • Device sterilization/disinfection container, reusable

Medtronic Reusable Instruments - 00681490912235

INSTRUMENT 922502S Q C STRT PED SPATULA
MEDTRONIC SOFAMOR DANEK, INC.
922502S
In Commercial Distribution

  • 00681490912235 ()


  • General-purpose surgical spatula

Medtronic Reusable Instruments - 00681490912211

INSTRUMENT 922501L Q C LONG SQUARE AWL
MEDTRONIC SOFAMOR DANEK, INC.
922501L
In Commercial Distribution

  • 00681490912211 ()


  • Bone awl, reusable

Medtronic Reusable Instruments - 00681490912204

INSTRUMENT 922501S Q C SHORT SQUARE AWL
MEDTRONIC SOFAMOR DANEK, INC.
922501S
In Commercial Distribution

  • 00681490912204 ()


  • Bone awl, reusable

Fisher & Paykel Healthcare - 09420012427069

F&P Pilairo Q Nasal Pillows Mask
FISHER & PAYKEL HEALTHCARE LIMITED
400421
In Commercial Distribution

  • 09420012427076 ()
  • 09420012427069 ()
400421

  • CPAP/BPAP nasal mask, reusable

Fisher & Paykel Healthcare - 09420012425546

Zest Q Plus Nasal Mask (Sleep Lab)
FISHER & PAYKEL HEALTHCARE LIMITED
400446SL
In Commercial Distribution

  • 09420012425546 ()
  • 09420012427335 ()
400446SL

  • CPAP/BPAP nasal mask, reusable
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