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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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OsteoXcell BA - 05060548020217

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 1cc, suspended in a biocompatible hydrogel solution packed in a 3 ml open bore syringes. Packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch. Packed in a carton box.
BIOSTONE CO. LIMITED
OSBA-001
In Commercial Distribution

  • 05060548020217 ()
OSBA-001

  • Bone matrix implant, synthetic, non-antimicrobial

si_Mochi - 05060548020088

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 1cc, suspended in a biocompatible hydrogel solution packed in a 3 ml open bore syringes. Packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch. Packed in a carton box.
BIOSTONE CO. LIMITED
OBS1201
In Commercial Distribution

  • 05060548020088 ()
OBS1201

  • Bone matrix implant, synthetic, non-antimicrobial

Zethon - 05060528015417

BUR - 3.18MM, COARSE DIAMOND BALL, 140MM X 6.0MM
ZETHON LIMITED
D14-06071
In Commercial Distribution

  • 15060528015414 ()
  • 05060528015417 ()


  • Orthopaedic bur, single-use

Zethon - 05060528015332

BUR - 3.18MM, FINE DIAMOND BALL, 140MM X 5.0MM
ZETHON LIMITED
D14-05051
In Commercial Distribution

  • 15060528015339 ()
  • 05060528015332 ()


  • Orthopaedic bur, single-use

Zethon - 05060528015295

BUR - 3.18MM, FINE DIAMOND BALL, 140MM X 4.0MM
ZETHON LIMITED
D14-04051
In Commercial Distribution

  • 15060528015292 ()
  • 05060528015295 ()


  • Orthopaedic bur, single-use

Zethon - 05060528015257

BUR - 3.18MM, FINE DIAMOND MATCH, 140MM X 3.0MM
ZETHON LIMITED
D14-03054
In Commercial Distribution

  • 15060528015254 ()
  • 05060528015257 ()


  • Orthopaedic bur, single-use

Zethon - 05060528015134

BUR - 3.18MM, COARSE DIAMOND BALL, 90MM X 6.0MM
ZETHON LIMITED
D09-06071
In Commercial Distribution

  • 15060528015131 ()
  • 05060528015134 ()


  • Orthopaedic bur, single-use

Zethon - 05060528015035

BUR - 3.18MM, FINE DIAMOND MATCH, 90MM X 3.0MM
ZETHON LIMITED
D09-03054
In Commercial Distribution

  • 15060528015032 ()
  • 05060528015035 ()


  • Orthopaedic bur, single-use

Zethon - 05060528014762

BUR - 2.38MM, COARSE DIAMOND BALL, 150MM X 6.0MM
ZETHON LIMITED
C15-06071
In Commercial Distribution

  • 15060528014769 ()
  • 05060528014762 ()


  • Orthopaedic bur, single-use

Zethon - 05060528014687

BUR - 2.38MM, FINE DIAMOND BALL, 150MM X 5.0MM
ZETHON LIMITED
C15-05051
In Commercial Distribution

  • 15060528014684 ()
  • 05060528014687 ()


  • Orthopaedic bur, single-use
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