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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2.5cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN010
In Commercial Distribution

  • 00865179000066 ()
IQSP-PP-102

  • Synthetic bone graft
5cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN009
In Commercial Distribution

  • 00865179000059 ()
IQSP-PP-105

  • Synthetic bone graft
10cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN008
In Commercial Distribution

  • 00865179000042 ()
IQSP-PP-110

  • Synthetic bone graft
OPTIVAC KIT TRIPLE MIX 120GM
Encore Medical, L.P.
600-50-120
In Commercial Distribution

  • 00190446138068 ()


  • Orthopaedic cement, non-antimicrobial
OPTIVAC KIT DOUBLE MIX 80GM
Encore Medical, L.P.
600-50-080
In Commercial Distribution

  • 00190446138051 ()


  • Orthopaedic cement, non-antimicrobial
OPTIVAC KIT SINGLE MIX 40GM
Encore Medical, L.P.
600-50-040
In Commercial Distribution

  • 00190446138044 ()


  • Orthopaedic cement, non-antimicrobial
CRANIOS REINFORCED ROTARY MIX 10CC-STERILE
Synthes GmbH
616.10.01S
In Commercial Distribution

  • H9806161001S0 ()
  • 10887587058696 ()
6161001S

  • Bone matrix implant, synthetic, non-antimicrobial
CRANIOS REINFORCED ROTARY MIX 3CC-STERILE
Synthes GmbH
616.03.01S
In Commercial Distribution

  • H9806160301S0 ()
  • 10887587058672 ()
6160301S

  • Bone matrix implant, synthetic, non-antimicrobial
CRANIOS REINFORCED ROTARY MIX 5CC-STERILE
Synthes GmbH
616.05.01S
In Commercial Distribution

  • H9806160501S0 ()
  • 10887587058689 ()
6160501S

  • Bone matrix implant, synthetic, non-antimicrobial
OPTIVAC MAX CAPACITY TRIPLE MIX (HIGH VOL CEMENT)
Encore Medical, L.P.
600-99-003
In Commercial Distribution

  • 00190446138167 ()


  • Coated elbow humerus prosthesis
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