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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LPL Medial Tibia Plate 9 H
Acumed LLC
70-0229-S
In Commercial Distribution

  • 10806378033704 ()


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Locking Lateral Fibula Plate 9 H
Acumed LLC
70-0169-S
In Commercial Distribution

  • 10806378033612 ()


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
LPL Lateral Fibula Plate 9 H
Acumed LLC
70-0149-S
In Commercial Distribution

  • 10806378033544 ()


  • Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
EMPERION TRIAL NECK REDUCED OFFSET 9
Smith & Nephew, Inc.
71361399
Not in Commercial Distribution

  • 03596010569431 ()
71361399

  • Femoral stem prosthesis trial
EMPERION STEM 9 STANDARD OFFSET 140MM
Smith & Nephew, Inc.
71290902
In Commercial Distribution

  • 03596010561275 ()
71290902

  • Press-fit femoral stem prosthesis
EMPERION STEM 9 REDUCED OFFSET 140MM
Smith & Nephew, Inc.
71290901
In Commercial Distribution

  • 03596010561268 ()
71290901

  • Press-fit femoral stem prosthesis
LEGION TRIAL STEM 9 X 160
Smith & Nephew, Inc.
71434042
In Commercial Distribution

  • 03596010547644 ()
71434042

  • Knee femur prosthesis trial, reusable
Johns Hopkins Bulldog Clamp Applier, 9"
BOSS INSTRUMENTS, LTD., INC.
65-6835
In Commercial Distribution

  • 00888515113480 ()
65-6835

  • Surgical bulldog clamp, reusable
Bahnson Aortic Clamp, 9 1/8"
BOSS INSTRUMENTS, LTD., INC.
65-6668
In Commercial Distribution

  • 00888515112551 ()
65-6668

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
Stoney Spleno-Renal Shunt Clamp, med, 9"
BOSS INSTRUMENTS, LTD., INC.
65-6616
In Commercial Distribution

  • 00888515112322 ()
65-6616

  • Surgical soft-tissue manipulation forceps, scissors-like, reusable
9 Panel Cup Drug Test, AMP-BZO-COC-MET-MTD-OPI-OXY-PCP-THC
Express Diagnostic Int'l, Inc.
60967
In Commercial Distribution

  • B2986096710 ()
60967

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BZO-COC-MET-MTD-OPI-OXY-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60967
Not in Commercial Distribution

  • B298609670 ()
60967

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60960
Not in Commercial Distribution

  • B298609600 ()
60960

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BZO-COC-MET-MTD-OPI-OXY-TCA-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60942
Not in Commercial Distribution

  • B298609420 ()
60942

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BZO-COC-MDMA-MET-MTD-OPI-OXY-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60939
Not in Commercial Distribution

  • B298609390 ()
60939

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP500-BARB-BZO-COC150-MET500-MTD-OPI300-OXY-THC20
Express Diagnostic Int'l, Inc.
60936
In Commercial Distribution

  • B2986093610 ()
60936

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MTD-OPI-PCP-PPX-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60931
Not in Commercial Distribution

  • B298609310 ()
60931

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI300-OXY-THC
Express Diagnostic Int'l, Inc.
60930
In Commercial Distribution

  • B2986093010 ()
60930

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI300-OXY-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60930
Not in Commercial Distribution

  • B298609300 ()
60930

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-OXY-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60929
Not in Commercial Distribution

  • B298609290 ()
60929

  • 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.
60925
In Commercial Distribution

  • B2986092510 ()
60925

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60925
In Commercial Distribution

  • B298609250 ()
60925

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, BAR-BZO-COC-MET-MTD-OPI300-OXY-PPX-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60923
Not in Commercial Distribution

  • B298609230 ()
60923

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI300-OXY-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60921
Not in Commercial Distribution

  • B298609210 ()
60921

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BARB-BZO-COC-MET-MTD-OPI-OXY-PCP
Express Diagnostic Int'l, Inc.
60918
In Commercial Distribution

  • B298609180 ()
60918

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BARB-BUP-BZO-COC-MET-MTD-OPI300-OXY
Express Diagnostic Int'l, Inc.
60915
In Commercial Distribution

  • B2986091510 ()
60915

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MTD-OPI300-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60914
Not in Commercial Distribution

  • B298609140 ()
60914

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, BZO-COC-MDMA-MET-MTD-OPI300-OXY-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60910
Not in Commercial Distribution

  • B298609100 ()
60910

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI300-OXY
Express Diagnostic Int'l, Inc.
60907
In Commercial Distribution

  • B2986090710 ()
60907

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MDMA-MET-MTD-OPI300-OXY
EXPRESS DIAGNOSTICS INT'L, INC.
60907
Not in Commercial Distribution

  • B298609070 ()
60907

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-OPI-OXY-PCP-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60904
Not in Commercial Distribution

  • B298609040 ()
60904

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-OPI300-PCP-TCA-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60903
Not in Commercial Distribution

  • B298609030 ()
60903

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, BAR-BZO-COC-MET-MTD-OPI-PCP-PPX-THC
EXPRESS DIAGNOSTICS INT'L, INC.
60902
Not in Commercial Distribution

  • B298609020 ()
60902

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