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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Origin R Broach Size 18
ORTHOMEDFLEX LLC
112-44-1118
In Commercial Distribution

  • M7161124411180 ()


  • Orthopaedic broach
Origin R Broach Size 16
ORTHOMEDFLEX LLC
112-44-1116
In Commercial Distribution

  • M7161124411160 ()


  • Orthopaedic broach
Origin R Broach Size 14
ORTHOMEDFLEX LLC
112-44-1114
In Commercial Distribution

  • M7161124411140 ()


  • Orthopaedic broach
Origin R Broach Size 12
ORTHOMEDFLEX LLC
112-44-1112
In Commercial Distribution

  • M7161124411120 ()


  • Orthopaedic broach
Origin R Broach Size 10
ORTHOMEDFLEX LLC
112-44-1110
In Commercial Distribution

  • M7161124411100 ()


  • Orthopaedic broach
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 18, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1801
In Commercial Distribution

  • M7161111818010 ()
111-18-1801

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 16, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1601
In Commercial Distribution

  • M7161111816010 ()
111-18-1601

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 14, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1401
In Commercial Distribution

  • M7161111814010 ()
111-18-1401

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Lateralized High Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1301
In Commercial Distribution

  • M7161111813010 ()
111-18-1301

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 13, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1300
In Commercial Distribution

  • M7161111813000 ()
111-18-1300

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 12, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1200
In Commercial Distribution

  • M7161111812000 ()
111-18-1200

  • Press-fit femoral stem prosthesis
Origin Hip Stem, Standard Offset Collarless, Cementless - Size 11, Ti6AI4V Alloy with HA Coating
ORTHOMEDFLEX LLC
111-18-1100
In Commercial Distribution

  • M7161111811000 ()
111-18-1100

  • Press-fit femoral stem prosthesis
Origin Instant Oral Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
81025-OD-EI
In Commercial Distribution

  • B77881025ODEI0 ()
81025-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
80600-OD-EI
In Commercial Distribution

  • B77880600ODEI0 ()
80600-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI
ORIGIN DIAGNOSTICS LLC
80510-OD-EI
In Commercial Distribution

  • B77880510ODEI0 ()
80510-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-THC-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
61147-3-OD
In Commercial Distribution

  • B778611473OD0 ()
61147-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-PCP-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
61013-3-OD
In Commercial Distribution

  • B778610133OD0 ()
61013-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
61007-3-OD
In Commercial Distribution

  • B778610073OD0 ()
61007-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
60500-OD-OTC
In Commercial Distribution

  • B77860500ODOTC0 ()
60500-OD-OTC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-COC-MET-OPI-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
60440-3-OD
In Commercial Distribution

  • B778604403OD0 ()
60440-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Dip Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI300-OXY-THC
ORIGIN DIAGNOSTICS LLC
30940-OD
In Commercial Distribution

  • B77830940OD0 ()
30940-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Dip Drug Test, BZO-COC-MET-OPI300-THC
ORIGIN DIAGNOSTICS LLC
30573-OD
In Commercial Distribution

  • B77830573OD0 ()
30573-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Dip Drug Test, AMP-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
30500-OD
In Commercial Distribution

  • B77830500OD0 ()
30500-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
81026-OD-EI
In Commercial Distribution

  • B77881026ODEI0 ()
81026-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
80902-OD-EI
In Commercial Distribution

  • B77880902ODEI0 ()
80902-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-COC-MET-OPI-THC
ORIGIN DIAGNOSTICS LLC
80502-OD-EI
In Commercial Distribution

  • B77880502ODEI0 ()
80502-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Oral Drug Test, AMP-COC-MET-OPI
ORIGIN DIAGNOSTICS LLC
80409-OD-EI
In Commercial Distribution

  • B77880409ODEI0 ()
80409-OD-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-PCP-THC
ORIGIN DIAGNOSTICS LLC
61025-OD
In Commercial Distribution

  • B77861025OD0 ()
61025-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC
ORIGIN DIAGNOSTICS LLC
61007-OD-OTC
In Commercial Distribution

  • B77861007ODOTC0 ()
61007-OD-OTC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Drug Test, AMP-BZO-COC-MET-OPI-THC-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
60600-3-OD
In Commercial Distribution

  • B778606003OD0 ()
60600-3-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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