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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 - 07445161010643

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi 575 cc
Establishment Labs S.A.
ERSD-575
In Commercial Distribution

  • 07445161010643 ()
ERSD-575

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161010636

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi 525 cc
Establishment Labs S.A.
ERSD-525
In Commercial Distribution

  • 07445161010636 ()
ERSD-525

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161010629

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi 475 cc
Establishment Labs S.A.
ERSD-475
In Commercial Distribution

  • 07445161010629 ()
ERSD-475

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161010612

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi 425 cc
Establishment Labs S.A.
ERSD-425
In Commercial Distribution

  • 07445161010612 ()
ERSD-425

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161010605

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi 380 cc
Establishment Labs S.A.
ERSD-380
In Commercial Distribution

  • 07445161010605 ()
ERSD-380

  • Silicone gel-filled breast implant, smooth-surface

Motiva® SmoothSilk® Round Ergonomix Breast Implant - 07445161010599

Motiva® SmoothSilk® Round Ergonomix Breast Implant Round Ergonomix Breast Implant - Demi 360 cc
Establishment Labs S.A.
ERSD-360
In Commercial Distribution

  • 07445161010599 ()
ERSD-360

  • Silicone gel-filled breast implant, smooth-surface

LINEUM OCT SPINE SYSTEM - 00888480609810

No Description
BIOMET SPINE LLC
14-524750
In Commercial Distribution

  • 00888480609810 ()

  • LINEUM 4.35MM X 50MM CC SCREW
14-524750

  • Bone-screw internal spinal fixation system, non-sterile

LINEUM OCT SPINE SYSTEM - 00888480609803

No Description
BIOMET SPINE LLC
14-524748
In Commercial Distribution

  • 00888480609803 ()

  • LINEUM 4.35MM X 48MM CC SCREW
14-524748

  • Bone-screw internal spinal fixation system, non-sterile

LINEUM OCT SPINE SYSTEM - 00888480609797

No Description
BIOMET SPINE LLC
14-524746
In Commercial Distribution

  • 00888480609797 ()

  • LINEUM 4.35MM X 46MM CC SCREW
14-524746

  • Bone-screw internal spinal fixation system, non-sterile

LINEUM OCT SPINE SYSTEM - 00888480609780

No Description
BIOMET SPINE LLC
14-524716
In Commercial Distribution

  • 00888480609780 ()

  • LINEUM 4.35MM X 16MM CC SCREW
14-524716

  • Bone-screw internal spinal fixation system, non-sterile
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