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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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Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini 205 cc
Establishment Labs S.A.
ERSM-205
In Commercial Distribution

  • 07445161010339 ()
ERSM-205

  • Silicone gel-filled breast implant, smooth-surface
Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini 185 cc
Establishment Labs S.A.
ERSM-185
In Commercial Distribution

  • 07445161010322 ()
ERSM-185

  • Silicone gel-filled breast implant, smooth-surface
Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini 170 cc
Establishment Labs S.A.
ERSM-170
In Commercial Distribution

  • 07445161010315 ()
ERSM-170

  • Silicone gel-filled breast implant, smooth-surface
Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini 160 cc
Establishment Labs S.A.
ERSM-160
In Commercial Distribution

  • 07445161010308 ()
ERSM-160

  • Silicone gel-filled breast implant, smooth-surface
Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Mini 150 cc
Establishment Labs S.A.
ERSM-150
In Commercial Distribution

  • 07445161010292 ()
ERSM-150

  • Silicone gel-filled breast implant, smooth-surface
No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio Socket Graft 1.0 cc
In Commercial Distribution

  • 00860010170113 ()


  • Synthetic bone graft
No Description
STEINER BIOTECHNOLOGY LLC.
SteinerBio Socket Graft 0.5 cc
In Commercial Distribution

  • 00860010170106 ()


  • Synthetic bone graft
Manual - Ratchet - Fix Key for Prosthetic D.1.20 mm. Short L.8 mm. - CC - IH - EH
FAICO MEDICAL LLC
AST12SHOAPCRB
Not in Commercial Distribution

  • 00840192704498 ()


  • Dental implant system
Manual - Ratchet - Fix Key for Prosthetic D.1.20 mm. Long L.14 mm. - CC- IH - EH
FAICO MEDICAL LLC
AST12000APCRB
Not in Commercial Distribution

  • 00840192704481 ()


  • Dental implant system
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
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