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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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AoN Implants - 00840192704351

Manual - Ratchet - Fix Key for Implant - Extra Long L.19 mm. - CC
FAICO MEDICAL LLC
AST00300APCRC
Not in Commercial Distribution

  • 00840192704351 ()


  • Dental implant system

OTIS-C PLUS - 03760154004152

NON STERILE 316L stainless steel screw, for use with mini-invasive OTIS-C PLUS plate. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml#
S.B.M
NON STERILE Screw for OTIS-C PLUS plate fixation
Not in Commercial Distribution

  • 03760154004152 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 70 Millimeter
EVONS66070

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

AoN Implants - 00840192716408

Manual - Ratchet - Fix Key for Implant - Extra Extra Long L.25 mm. - CC
FAICO MEDICAL LLC
AST00250APCRC
Not in Commercial Distribution

  • 00840192716408 ()


  • Dental implant system

Motiva® SmoothSilk® Round Breast Implant - 07445161002174

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 625 cc
Establishment Labs S.A.
RSF-625+
In Commercial Distribution

  • 07445161002174 ()
RSF-625+

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Breast Implant - 07445161002167

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 550 cc
Establishment Labs S.A.
RSF-550+
In Commercial Distribution

  • 07445161002167 ()
RSF-550+

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Breast Implant - 07445161002150

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 500 cc
Establishment Labs S.A.
RSF-500+
In Commercial Distribution

  • 07445161002150 ()
RSF-500+

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Breast Implant - 07445161002143

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 450 cc
Establishment Labs S.A.
RSF-450+
In Commercial Distribution

  • 07445161002143 ()
RSF-450+

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Breast Implant - 07445161002136

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 425 cc
Establishment Labs S.A.
RSF-425+
In Commercial Distribution

  • 07445161002136 ()
RSF-425+

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Breast Implant - 07445161002129

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 400 cc
Establishment Labs S.A.
RSF-400+
In Commercial Distribution

  • 07445161002129 ()
RSF-400+

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Breast Implant - 07445161002112

Motiva® SmoothSilk® Round Breast Implant Round Breast Implant - Full 375 cc
Establishment Labs S.A.
RSF-375+
In Commercial Distribution

  • 07445161002112 ()
RSF-375+

  • Silicone gel-filled breast implant, smooth-surface
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