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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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GUARDIAN-SG Inflatable Bone Expander System - 08809255540987

The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine.
BM KOREA CO., LTD
2BMK(T)15αS
In Commercial Distribution

  • 08809255540987 ()

  • Length: 15 Millimeter


  • Catheter/overtube balloon inflator, single-use

S/ETCH - 09336472012052

S/ETCH JUMBO 2X25ML SYR
SDI LIMITED
8100059
In Commercial Distribution

  • 09336472012052 ()
8100059

  • Dental etching solution

S/ETCH - 09336472012007

S/ETCH 12GM SYR WITH TIPS
SDI LIMITED
8100052
In Commercial Distribution

  • 09336472012007 ()
8100052

  • Dental etching solution

S/ETCH - 09336472011963

S/ETCH 10X2ML SYR KT
SDI LIMITED
8100045
In Commercial Distribution

  • 09336472011963 ()
8100045

  • Dental etching solution

S/ETCH - 09336472011932

S/ETCH 3X2ML SYR KT
SDI LIMITED
8100040
In Commercial Distribution

  • 09336472011932 ()
8100040

  • Dental etching solution

Touch N Heat - 00889989069532

MODEL 5004, 110V
ORMCO CORPORATION
973-0212
In Commercial Distribution

  • 00889989069532 ()


  • Endodontic filling material condenser

System B - 00889989068412

Heat Source, Model 1005
ORMCO CORPORATION
952-0001
In Commercial Distribution

  • 00889989068412 ()


  • Endodontic filling material condenser

Elements - 00889989061888

ELEMENTS DIAGNOSTIC UNIT W/O SATELLITE
ORMCO CORPORATION
973-0320
In Commercial Distribution

  • 00889989061888 ()


  • Dental pulp analysis system

Elements - 00889989061871

ELEMENTS DIAGNOSTIC UNIT
ORMCO CORPORATION
973-0300
In Commercial Distribution

  • 00889989061871 ()


  • Dental pulp analysis system

Vitality Scanner - 00889989069709

VITALITY SCANNER 2006
ORMCO CORPORATION
973-0234
Not in Commercial Distribution

  • 00889989069709 ()


  • Dental pulp analysis system
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