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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9 Panel Cup Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60901
Not in Commercial Distribution

  • B298609010 ()
60901

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-OPI-PCP-TCA-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60900
Not in Commercial Distribution

  • B298609000 ()
60900

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-PCP-THC
Express Diagnostic Int'l, Inc.
50900-DC
In Commercial Distribution

  • B29850900DC10 ()
50900-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
50900-DC
Not in Commercial Distribution

  • B29850900DC0 ()
50900-DC

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
polycon cast 9 units bridge framework
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031703323 ()
010.4009

  • Dental bridge, polymer
ticon Titanium 9 units bridge framework
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031703156 ()
010.2009

  • Dental bridge, metal-ceramic
coron CoCr 9 units bridge framework
Institut Straumann AG
Bridges (tooth borne)
In Commercial Distribution

  • 07630031701756 ()
010.1009

  • Dental bridge, metal-ceramic
Plugger, Gutta Percha Heater 9, Double-Ended
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
017-24602
Not in Commercial Distribution

  • H834017246020 ()
  • 10381780203223 ()
017-24602

  • Endodontic plugger
COMBINE ABD PAD, 5 x 9
MCKESSON MEDICAL-SURGICAL INC.
42-50
In Commercial Distribution

  • 00815555023189 ()
  • 00815555023172 ()
  • 00815555023196 ()


  • Non-woven gauze pad
MICRO KERRISON, 40DEG UP, 9", 4MM
BOSS INSTRUMENTS, LTD., INC.
SS4065
In Commercial Distribution

  • 00888515272484 ()
SS4065

  • Spinal rongeur
MICRO KERRISON, 40DEG UP, 9", 1.5MM
BOSS INSTRUMENTS, LTD., INC.
SS4062
In Commercial Distribution

  • 00888515272453 ()
SS4062

  • Spinal rongeur
Bunnell tendon Passers, malleable, 5mm, 9"
BOSS INSTRUMENTS, LTD., INC.
96-5768
In Commercial Distribution

  • 00888515253124 ()
96-5768

  • Tendon/ligament tunneller
Brand Tendon Fcp, 9 1/2"
BOSS INSTRUMENTS, LTD., INC.
96-5706
In Commercial Distribution

  • 00888515252844 ()
96-5706

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Ombredanne Mallet, 550g, 9 1/2"
BOSS INSTRUMENTS, LTD., INC.
93-0234
In Commercial Distribution

  • 00888515237810 ()
93-0234

  • Surgical mallet
9 Panel Dip Drug Test, BUP-BZO-COC-MET-MTD-OPI300-OXY-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30980
Not in Commercial Distribution

  • B298309800 ()
30980

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-COC-OPI300-MET-THC-BZO-BUP-OXY-MTD
EXPRESS DIAGNOSTICS INT'L, INC.
30970
Not in Commercial Distribution

  • B298309700 ()
30970

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI300-OXY-THC
Express Diagnostic Int'l, Inc.
30960
In Commercial Distribution

  • B2983096010 ()
30960

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI300-OXY-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30960
Not in Commercial Distribution

  • B298309600 ()
30960

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30949
Not in Commercial Distribution

  • B298309490 ()
30949

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BAR-BZO-COC-MDMA-MET-OPI300-TCA-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30933
Not in Commercial Distribution

  • B298309330 ()
30933

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BAR-COC-MDMA-MET-OPI-OXY-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30925
Not in Commercial Distribution

  • B298309250 ()
30925

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP500-BARB-BZO-COC150-MET500-MTD-OPI300-OXY-THC20
Express Diagnostic Int'l, Inc.
30921
In Commercial Distribution

  • B2983092110 ()
30921

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BAR-BZO-COC150-MDMA-MET500-OPI300-TCA-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30914
Not in Commercial Distribution

  • B298309140 ()
30914

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BZO-COC-MTD-OPI-OPI300-OXY-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30909
Not in Commercial Distribution

  • B298309090 ()
30909

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BARB-BZO-COC-MET500-MTD-OPI300-OXY-THC
Express Diagnostic Int'l, Inc.
30908
In Commercial Distribution

  • B298309080 ()
30908

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP500-BARB-BZO-COC150-MET500-MTD-OPI300-OXY-THC
Express Diagnostic Int'l, Inc.
30907
In Commercial Distribution

  • B2983090710 ()
30907

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-PCP-THC
Express Diagnostic Int'l, Inc.
30906
In Commercial Distribution

  • B2983090610 ()
30906

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30906
Not in Commercial Distribution

  • B298309060 ()
30906

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI300-OXY-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30904
Not in Commercial Distribution

  • B298309040 ()
30904

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30903
Not in Commercial Distribution

  • B298309030 ()
30903

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BARB-BUP-BZO-COC-MTD-OPI300-OXY-THC
Express Diagnostic Int'l, Inc.
30902
In Commercial Distribution

  • B2983090210 ()
30902

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BAR-BUP-BZO-COC-MTD-OPI300-OXY-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30902
Not in Commercial Distribution

  • B298309020 ()
30902

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BZO-COC-MET-MTD-OPI300-OXY-PPX-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30901
Not in Commercial Distribution

  • B298309010 ()
30901

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Dip Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI300-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30900
Not in Commercial Distribution

  • B298309000 ()
30900

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DX Stride M 9 (amber suede)
Unitron Hearing Division
050-6393-S2
In Commercial Distribution

  • 07613389413366 ()
050-6393-S2

  • Air-conduction hearing aid, behind-the-ear
DX Insera 9 W 312 Dir
Unitron Hearing Division
063-6224-01
In Commercial Distribution

  • 07613389405958 ()
063-6224-01

  • Air-conduction hearing aid, in-the-ear
DX Moxi Move R 9 (cinnamon)
Unitron Hearing Division
050-6253-Q9
In Commercial Distribution

  • 07613389355376 ()
050-6253-Q9

  • Air-conduction hearing aid, receiver-in-canal
DX Moxi Move R 9 (charcoal)
Unitron Hearing Division
050-6253-P8
In Commercial Distribution

  • 07613389355369 ()
050-6253-P8

  • Air-conduction hearing aid, receiver-in-canal
DX Moxi Move R 9 (pewter)
Unitron Hearing Division
050-6253-P7
In Commercial Distribution

  • 07613389355352 ()
050-6253-P7

  • Air-conduction hearing aid, receiver-in-canal
DX Moxi Move R 9 (platinum)
Unitron Hearing Division
050-6253-P6
In Commercial Distribution

  • 07613389355345 ()
050-6253-P6

  • Air-conduction hearing aid, receiver-in-canal
DX Moxi Move R 9 (espresso)
Unitron Hearing Division
050-6253-P4
In Commercial Distribution

  • 07613389355338 ()
050-6253-P4

  • Air-conduction hearing aid, receiver-in-canal
DX Moxi Move R 9 (amber)
Unitron Hearing Division
050-6253-P2
In Commercial Distribution

  • 07613389355321 ()
050-6253-P2

  • Air-conduction hearing aid, receiver-in-canal
DX Stride P R 9 (cinnamon)
Unitron Hearing Division
050-6265-Q9
In Commercial Distribution

  • 07613389340457 ()
050-6265-Q9

  • Air-conduction hearing aid, behind-the-ear
DX Stride P R 9 (charcoal)
Unitron Hearing Division
050-6265-P8
In Commercial Distribution

  • 07613389340440 ()
050-6265-P8

  • Air-conduction hearing aid, behind-the-ear
DX Stride P R 9 (pewter)
Unitron Hearing Division
050-6265-P7
In Commercial Distribution

  • 07613389340433 ()
050-6265-P7

  • Air-conduction hearing aid, behind-the-ear
DX Stride P R 9 (platinum)
Unitron Hearing Division
050-6265-P6
In Commercial Distribution

  • 07613389340426 ()
050-6265-P6

  • Air-conduction hearing aid, behind-the-ear
DX Stride P R 9 (espresso)
Unitron Hearing Division
050-6265-P4
In Commercial Distribution

  • 07613389340419 ()
050-6265-P4

  • Air-conduction hearing aid, behind-the-ear
DX Moxi Fit 9 (amber suede)
Unitron Hearing Division
050-6259-S2
In Commercial Distribution

  • 07613389340167 ()
050-6259-S2

  • Air-conduction hearing aid, receiver-in-canal
DX Moxi Fit 9 (amber beige)
Unitron Hearing Division
050-6259-P2
In Commercial Distribution

  • 07613389340105 ()
050-6259-P2

  • Air-conduction hearing aid, receiver-in-canal
DX Stride P R 9 (beige)
Unitron Hearing Division
050-6265-01
In Commercial Distribution

  • 07613389335576 ()
050-6265-01

  • Air-conduction hearing aid, behind-the-ear
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