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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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SURGICEL NU-KNIT - 10705031002999

Absorbable Hemostat (oxidized regenerated cellulose)
Ethicon Sàrl
1946
In Commercial Distribution

  • 20705031002996 ()
  • 10705031002999 ()
1946

  • Plant polysaccharide haemostatic agent, bioabsorbable

BELLAFILL - 00350224000141

Bellafill 1.5ml on 1.5cc syringe
SUNEVA MEDICAL, INC.
1.5 cc
In Commercial Distribution

  • 10350224000148 ()
  • 00350224000141 ()
  • 20350224000145 ()
  • 30350224000142 ()
GBF0115, GBF0215, GBF0315

  • Dermal tissue reconstructive material, animal-derived

BELLAFILL - 00350224000028

Bellafill 0.8ml on 1.0cc syringe
SUNEVA MEDICAL, INC.
1.0 cc
In Commercial Distribution

  • 00350224000028 ()
  • 10350224000025 ()
  • 20350224000022 ()
GBF0208, GBF0508

  • Dermal tissue reconstructive material, animal-derived

Anti-HBs CalCheck - 07613336159804

Anti-HBs CC 3 Elecsys
Roche Diagnostics GmbH
04985354160
Not in Commercial Distribution

  • 07613336159804 ()
04985354160

  • Hepatitis B virus surface total antibody IVD, control

i-FACTOR™ Peptide Enhanced Bone Graft - 00850001680028

i-FACTOR™ Putty, 5.0 cc Syringe
Cerapedics Inc.
700-050
In Commercial Distribution

700-050

  • Bone matrix implant, animal-derived, bioabsorbable

i-FACTOR™ Peptide Enhanced Bone Graft - M8517000501

i-FACTOR™ Putty, 5.0 cc Syringe
Cerapedics Inc.
700-050
In Commercial Distribution

  • M8517000501 ()
700-050

  • Bone matrix implant, animal-derived, bioabsorbable

Natrelle INSPIRA Breast Implants - 10888628008632

NATRELLE INSPIRA Sty TRX-800 Extra Full profile BIOCELL |textured|round|silicone
Allergan, Inc.
TRX-800
Not in Commercial Distribution

  • 10888628008632 ()

  • 800 cc
TRX-800

  • Silicone gel-filled breast implant, textured-surface

Natrelle INSPIRA Breast Implants - 10888628008625

NATRELLE INSPIRA Sty TRX-750 Extra Full profile BIOCELL |textured|round|silicone
Allergan, Inc.
TRX-750
Not in Commercial Distribution

  • 10888628008625 ()

  • 750 cc
TRX-750

  • Silicone gel-filled breast implant, textured-surface

Natrelle INSPIRA Breast Implants - 10888628008618

NATRELLE INSPIRA Sty TRX-700 Extra Full profile BIOCELL |textured|round|silicone
Allergan, Inc.
TRX-700
Not in Commercial Distribution

  • 10888628008618 ()

  • 700 cc
TRX-700

  • Silicone gel-filled breast implant, textured-surface

Natrelle INSPIRA Breast Implants - 10888628008601

NATRELLE INSPIRA Sty TRX-650 Extra Full profile BIOCELL |textured|round|silicone
Allergan, Inc.
TRX-650
Not in Commercial Distribution

  • 10888628008601 ()

  • 650 cc
TRX-650

  • Silicone gel-filled breast implant, textured-surface
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