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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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Wizard CaP - 00868201000133

Calcium Bone Void Filler (3 cc)
Vivorte, Inc
3 cc
Not in Commercial Distribution

  • 00868201000133 ()


  • Bone matrix implant, synthetic, non-antimicrobial

Trabexus ® - 00868201000126

Calcium compound bone void filler (10 cc)
Vivorte, Inc
10 cc
Not in Commercial Distribution

  • 00868201000126 ()
131133-10

  • Bone matrix implant, synthetic, non-antimicrobial

Trabexus ® - 00868201000119

Calcium compound bone void filler (5 cc)
Vivorte, Inc
5 cc
Not in Commercial Distribution

  • 00868201000119 ()
131133-05

  • Bone matrix implant, synthetic, non-antimicrobial

Trabexus ® - 00868201000102

Calcium compound bone void filler (3cc)
Vivorte, Inc
3 cc
Not in Commercial Distribution

  • 00868201000102 ()
131133-03

  • Bone matrix implant, synthetic, non-antimicrobial

CONFIDENCE - 03760177046344

No Description
TEKNIMED
11 CC
Not in Commercial Distribution

  • 03760177046344 ()
183901000

  • Vertebral bone filler, non-bioabsorbable

CONFIDENCE - 03760177043947

No Description
TEKNIMED
11 CC
Not in Commercial Distribution

  • 03760177043947 ()
183901000

  • Vertebral bone filler, non-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

Trabexus® - W4146EB0010T0475

Calcium compound bone void filler with DBM (10 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
10 cc
In Commercial Distribution

  • W4146EB0010T0475 ()
130703-10

  • Cadaveric-donor/synthetic mineral bone graft

Trabexus® - W4146EB0005T0475

Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.
Vivorte, Inc
5 cc
In Commercial Distribution

  • W4146EB0005T0475 ()
130703-05

  • Cadaveric-donor/synthetic mineral bone graft
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