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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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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
SR Ivocron Intensive 15 g 9
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
549985AN
In Commercial Distribution

549985AN

  • Dental prosthesis veneer resin
iBalance HTO Trial, 9 deg, 10.5mm
ARTHREX, INC.
SP-13400-09
In Commercial Distribution

  • 00888867261556 ()
  • M150SP13400090 ()
SP-13400-09

  • Knee tibia prosthesis trial, reusable
UNIVERS REVERS APEX STEM, SIZE 9
ARTHREX, INC.
AR-9501-09S
In Commercial Distribution

  • 00888867250505 ()
AR-9501-09S

  • Total reverse shoulder prosthesis
UNIVERS REVERS HUMERAL STEM, SIZE 9
ARTHREX, INC.
AR-9501-09P
In Commercial Distribution

  • M150AR950109P1 ()
  • 00888867250413 ()
AR-9501-09P

  • Total reverse shoulder prosthesis
Size #3, 9 mm thickness, LLRL
Medacta International SA
02.18.IF3.09.LLRL
In Commercial Distribution

  • 07630040720854 ()


  • Uncoated unicondylar knee tibia prosthesis, polyethylene
Ombredanne Mallet, 550g, 9 1/2"
BOSS INSTRUMENTS, LTD., INC.
93-0234
In Commercial Distribution

  • 00888515237810 ()
93-0234

  • Surgical mallet
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
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
Intra-Aortic Balloon: 9 Fr. 50 cc
TELEFLEX INCORPORATED
IPN039781
In Commercial Distribution

  • 10801902145601 ()
IAB-R950-U

  • Intra-aortic balloon catheter
Intra-Aortic Balloon: 9 Fr. 50 cc
TELEFLEX INCORPORATED
IPN039777
In Commercial Distribution

  • 10801902145595 ()
IAB-R950-U

  • Intra-aortic balloon catheter
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