Company Name Brand Name GMDN Term 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 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, immunochromatographic test (ICT), rapid
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, immunochromatographic test (ICT), rapid
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, immunochromatographic test (ICT), rapid
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, immunochromatographic test (ICT), rapid
Origin Instant Drug Test, AMP-COC-OPI-PCP-THC-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
60505-3-OD
In Commercial Distribution

  • B778605053OD0 ()
60505-3-OD

  • Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
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, immunochromatographic test (ICT), rapid
Origin Instant Drug Test, AMP-COC-MET-OPI-THC-pH,SG,OX
ORIGIN DIAGNOSTICS LLC
60500-3-OD
In Commercial Distribution

  • B778605003OD0 ()
60500-3-OD

  • Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
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, immunochromatographic test (ICT), rapid
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1409
In Commercial Distribution

  • 09348215039752 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1209
In Commercial Distribution

  • 09348215039738 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1109
In Commercial Distribution

  • 09348215039721 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0909
In Commercial Distribution

  • 09348215039707 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0809
In Commercial Distribution

  • 09348215039691 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1809
In Commercial Distribution

  • 09348215039783 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1609
In Commercial Distribution

  • 09348215039776 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1509
In Commercial Distribution

  • 09348215039769 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1309
In Commercial Distribution

  • 09348215039745 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1009
In Commercial Distribution

  • 09348215039714 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0609
In Commercial Distribution

  • 09348215039684 ()


  • Orthopaedic broach
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 18
In Commercial Distribution

  • 08177570205059 ()
PR111-18-1803

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 16
In Commercial Distribution

  • 08177570205042 ()
PR111-18-1603

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 15
In Commercial Distribution

  • 08177570205035 ()
PR111-18-1503

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 14
In Commercial Distribution

  • 08177570205028 ()
PR111-18-1403

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 13
In Commercial Distribution

  • 08177570205011 ()
PR111-18-1303

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 12
In Commercial Distribution

  • 08177570205004 ()
PR111-18-1203

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 11
In Commercial Distribution

  • 08177570204991 ()
PR111-18-1103

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 10
In Commercial Distribution

  • 08177570204984 ()
PR111-18-1003

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 9
In Commercial Distribution

  • 08177570204977 ()
PR111-18-0903

  • Coated femoral stem prosthesis, modular
No Description
PAXEON RECONSTRUCTION LLC
Origin Stem Lateral Offset Collared Size 8
In Commercial Distribution

  • 08177570204960 ()
PR111-18-0803

  • Coated femoral stem prosthesis, modular
Origin Stem, Standard Offset Size 18 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1802
In Commercial Distribution

  • 08177570200689 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1801
In Commercial Distribution

  • 08177570200672 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 18
PAXEON RECONSTRUCTION LLC
PR111-18-1800
In Commercial Distribution

  • 08177570200665 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 16 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1602
In Commercial Distribution

  • 08177570200641 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1601
In Commercial Distribution

  • 08177570200634 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 16
PAXEON RECONSTRUCTION LLC
PR111-18-1600
In Commercial Distribution

  • 08177570200627 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 15 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1502
In Commercial Distribution

  • 08177570200603 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1501
In Commercial Distribution

  • 08177570200597 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 15
PAXEON RECONSTRUCTION LLC
PR111-18-1500
In Commercial Distribution

  • 08177570200580 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 14 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1402
In Commercial Distribution

  • 08177570200566 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1401
In Commercial Distribution

  • 08177570200559 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 14
PAXEON RECONSTRUCTION LLC
PR111-18-1400
In Commercial Distribution

  • 08177570200542 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 13 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1302
In Commercial Distribution

  • 08177570200528 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1301
In Commercial Distribution

  • 08177570200511 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 13
PAXEON RECONSTRUCTION LLC
PR111-18-1300
In Commercial Distribution

  • 08177570200504 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 12 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1202
In Commercial Distribution

  • 08177570200481 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 12
PAXEON RECONSTRUCTION LLC
PR111-18-1201
In Commercial Distribution

  • 08177570200474 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 12
PAXEON RECONSTRUCTION LLC
PR111-18-1200
In Commercial Distribution

  • 08177570200467 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 11 Collared
PAXEON RECONSTRUCTION LLC
PR111-18-1102
In Commercial Distribution

  • 08177570200443 ()


  • Coated hip femur prosthesis, modular
Origin Stem, High Offset Size 11
PAXEON RECONSTRUCTION LLC
PR111-18-1101
In Commercial Distribution

  • 08177570200436 ()


  • Coated hip femur prosthesis, modular
Origin Stem, Standard Offset Size 11
PAXEON RECONSTRUCTION LLC
PR111-18-1100
In Commercial Distribution

  • 08177570200429 ()


  • Coated hip femur prosthesis, modular
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