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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OCS Lung Solution
TRANSMEDICS, INC.
2300
In Commercial Distribution

  • B00944671 ()
  • B00944670 ()

  • Height: 2.5 Inch
  • Width: 5.5 Inch
  • Length: 14 Inch
2300

  • Donor-organ/tissue/cell preservation solution
Absorbable Hemostat (oxidized regenerated cellulose)
Ethicon Sàrl
1946
In Commercial Distribution

  • 20705031002996 ()
  • 10705031002999 ()
1946

  • Plant polysaccharide haemostatic agent, bioabsorbable
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 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 CC 3 Elecsys
Roche Diagnostics GmbH
04985354160
Not in Commercial Distribution

  • 07613336159804 ()
04985354160

  • Hepatitis B virus surface total antibody IVD, control
i-FACTOR™ Putty, 5.0 cc Syringe
Cerapedics Inc.
700-050
In Commercial Distribution

700-050

  • Bone matrix implant, animal-derived, bioabsorbable
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 TSX 800cc Extra Full profile BIOCELL |textured|round|silicone
Allergan, Inc.
TSX-800
Not in Commercial Distribution

  • 10888628034464 ()

  • 800 cc
TSX-800

  • Silicone gel-filled breast implant, textured-surface
Natrelle Inspira TSX 750cc Extra Full profile BIOCELL |textured|round|silicone
Allergan, Inc.
TSX-750
Not in Commercial Distribution

  • 10888628034457 ()

  • 750 cc
TSX-750

  • Silicone gel-filled breast implant, textured-surface
Natrelle Inspira TSX 700cc Extra Full profile BIOCELL |textured|round|silicone
Allergan, Inc.
TSX-700
Not in Commercial Distribution

  • 10888628034440 ()

  • 700 cc
TSX-700

  • Silicone gel-filled breast implant, textured-surface
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