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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0800
In Commercial Distribution

  • 09348215051440 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0801
In Commercial Distribution

  • 09348215053345 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1804
In Commercial Distribution

  • 09348215051914 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1604
In Commercial Distribution

  • 09348215051907 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1504
In Commercial Distribution

  • 09348215051891 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1404
In Commercial Distribution

  • 09348215051884 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1304
In Commercial Distribution

  • 09348215051877 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1204
In Commercial Distribution

  • 09348215051860 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1104
In Commercial Distribution

  • 09348215051853 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1004
In Commercial Distribution

  • 09348215051846 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-0904
In Commercial Distribution

  • 09348215051839 ()


  • Coated femoral stem prosthesis, modular
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 Dip Drug Test, AMP-BARB-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-THC
ORIGIN DIAGNOSTICS LLC
31236-OD
In Commercial Distribution

  • B77831236OD0 ()
31236-OD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Origin Instant Dip Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-PCP-TCA-THC
ORIGIN DIAGNOSTICS LLC
31016-OD
In Commercial Distribution

  • B77831016OD0 ()
31016-OD

  • 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 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 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
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, rapid ICT, clinical
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, rapid ICT, clinical
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 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
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-001
In Commercial Distribution

  • 09348215039882 ()


  • Instrument tray, reusable
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0803
In Commercial Distribution

  • 09348215023836 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1803
In Commercial Distribution

  • 09348215017835 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1603
In Commercial Distribution

  • 09348215017828 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1503
In Commercial Distribution

  • 09348215017811 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1403
In Commercial Distribution

  • 09348215017804 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1303
In Commercial Distribution

  • 09348215017798 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1203
In Commercial Distribution

  • 09348215017781 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1103
In Commercial Distribution

  • 09348215017774 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-1003
In Commercial Distribution

  • 09348215017767 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-18-0903
In Commercial Distribution

  • 09348215017750 ()


  • Coated femoral stem prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5052
In Commercial Distribution

  • 09348215087289 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5051
In Commercial Distribution

  • 09348215087272 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5042
In Commercial Distribution

  • 09348215087265 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5041
In Commercial Distribution

  • 09348215087258 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5032
In Commercial Distribution

  • 09348215087241 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5031
In Commercial Distribution

  • 09348215087234 ()


  • Coated hip femur prosthesis, modular
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