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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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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
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
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
Calcium compound bone void filler with DBM (3 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
3 cc
In Commercial Distribution

  • W4146EB0003T0475 ()
130703-03

  • Cadaveric-donor/synthetic mineral bone graft
No Description
PARKS MEDICAL ELECTRONICS, INC.
812-1-901 CC
In Commercial Distribution

  • 00816787020427 ()


  • Laser Doppler blood flowmeter
No Description
PARKS MEDICAL ELECTRONICS, INC.
812-1-800 CC
In Commercial Distribution

  • 00816787020410 ()


  • Laser Doppler blood flowmeter
No Description
TEKNIMED
11 CC
Not in Commercial Distribution

  • 03760177046344 ()
183901000

  • Vertebral bone filler, non-bioabsorbable
No Description
TEKNIMED
11 CC
Not in Commercial Distribution

  • 03760177043947 ()
183901000

  • Vertebral bone filler, non-bioabsorbable
OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked.
DATUM DENTAL LTD
0.250 cc
In Commercial Distribution

  • 07290015477222 ()

  • Height: 5 Millimeter
  • Length: 10 Millimeter
  • Depth: 5 Millimeter
  • 0.250 cc
OXB0250

  • Dental bone matrix implant, synthetic
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