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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BAR Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BAR-114
In Commercial Distribution

  • 20817038020382 ()
  • 10817038020385 ()
  • 00817038020388 ()
U-BAR-114

  • Barbiturate IVD, kit, rapid ICT, clinical
TCA Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-TCA-114
In Commercial Distribution

  • 20817038020023 ()
  • 10817038020026 ()
  • 00817038020029 ()
U-TCA-114

  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
PPX Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-PPX-114
In Commercial Distribution

  • 20817038020016 ()
  • 10817038020019 ()
  • 00817038020012 ()
U-PPX-114

  • Propoxyphene IVD, kit, enzyme immunoassay (EIA)
OXY Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-OXY-114
In Commercial Distribution

  • 20817038020009 ()
  • 10817038020002 ()
  • 00817038020005 ()
U-OXY-114

  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
9 Panel Cutoff -/+ 25%, 5ML KITBOX
BIOCHEMICAL DIAGNOSTICS INC
18002907
In Commercial Distribution

  • 00810042680289 ()
18002907

  • Multiple drugs of abuse IVD, control
DOA IA PANEL, cutoff +25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008511
In Commercial Distribution

  • 00810042684188 ()
18008511

  • Multiple drugs of abuse IVD, control
DOA IA PANEL, cutoff -25%, 20mL
BIOCHEMICAL DIAGNOSTICS INC
18008510
In Commercial Distribution

  • 00810042684171 ()
18008510

  • Multiple drugs of abuse IVD, control
OF 5 Panel, 3X Cutoff, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200005
In Commercial Distribution

  • 00810042683709 ()
18200005

  • Multiple drugs of abuse IVD, control
OF 5 Panel, Cutoff +50%, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200177
In Commercial Distribution

  • 00810042683655 ()
18200177

  • Multiple drugs of abuse IVD, control
OF 5 Panel, Cutoff -50%, 25mL
BIOCHEMICAL DIAGNOSTICS INC
18200176
In Commercial Distribution

  • 00810042683648 ()
18200176

  • Multiple drugs of abuse IVD, control
nCare 4K 21.5" Medical Touch Panel
Gyrus ACMI, LLC
ISM-1200559
In Commercial Distribution

  • 00821925045941 ()


  • Operating room equipment remote control
ECLIPSE WIDE BACK PANEL VQ GRAY
Vision Quest Industries Incorporated
40-11000-030
In Commercial Distribution

  • 00817717020340 ()


  • Cervical spine collar, reusable
8 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEC-385
In Commercial Distribution

  • 20816490022446 ()
  • 10816490022449 ()
  • 00816490022442 ()
HCDOAEC-385

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
For use the MMR IHC Panel
Ventana Medical Systems, Inc.
790-5094
In Commercial Distribution

  • 07613336100592 ()
07862261001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • Postmeiotic segregation increased 2 (PMS2) IVD, antibody
For use with MMR IHC Panel
Ventana Medical Systems, Inc.
790-5092
In Commercial Distribution

  • 07613336100578 ()
07862245001

  • Hereditary nonpolyposis colon cancer (HNPCC) IVD, reagent
  • MSH6 antigen IVD, antibody
OneStep+ DOA Test Kit 14 Panel
HENRY SCHEIN, INC.
5701066
In Commercial Distribution

  • 10304040090302 ()
  • 00304040090305 ()
5701066

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
OneStep+ DOA Test Kit 10 Panel
HENRY SCHEIN, INC.
5701067
In Commercial Distribution

  • 10304040090289 ()
  • 00304040090282 ()
5701067

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
830 Singel Panel Knee Immobilizer 22"
VIVE HEALTH LLC
SUP3019BLK22
In Commercial Distribution

  • 10810113577453 ()
  • 00810113577456 ()


  • Knee support orthosis
830 Singel Panel Knee Immobilizer 14"
VIVE HEALTH LLC
SUP3019BLK14
In Commercial Distribution

  • 10810113577446 ()
  • 00810113577449 ()


  • Knee support orthosis
830 Single Panel Knee Immobilizer 27"
VIVE HEALTH LLC
SUP3019BLK27
In Commercial Distribution

  • 10810113570973 ()
  • 00810113570976 ()


  • Knee support orthosis
830 Single Panel Knee Immobilizer 24"
VIVE HEALTH LLC
SUP3019BLK24
In Commercial Distribution

  • 10810113570959 ()
  • 00810113570952 ()


  • Knee support orthosis
830 Single Panel Knee Immobilizer 20"
VIVE HEALTH LLC
SUP3019BLK20
In Commercial Distribution

  • 10810113570829 ()
  • 00810113570822 ()


  • Knee support orthosis
830 Single Panel Knee Immobilizer 16"
VIVE HEALTH LLC
SUP3019BLK16
In Commercial Distribution

  • 10810113570805 ()
  • 00810113570808 ()


  • Knee support orthosis
830 Singel Panel Knee Immobilizer 12"
VIVE HEALTH LLC
SUP3019BLK12
In Commercial Distribution

  • 10810113570799 ()
  • 00810113570792 ()


  • Knee support orthosis
830 Single Panel Knee Immobiliser 9"
VIVE HEALTH LLC
SUP3019BLK9
In Commercial Distribution

  • 10810113570782 ()
  • 00810113570785 ()


  • Knee support orthosis
11 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET500-MTD-OPI-OXY-PCP-TCA-THC
CLINICAL REFERENCE LABORATORY, INC.
51100
Not in Commercial Distribution

  • 81781502511007 ()
51100

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Assayed SA Nasal Complete Control Panel
MICROBIOLOGICS INC.
8196 Cepheid Xpert® SA Nasal Complete Control Panel
In Commercial Distribution

  • 70845357041233 ()
8196

  • MRSA/MSSA nucleic acid IVD, control
9 Panel Cup Drug Test, AMP-BAR-BZO-COC-MET-MTD-OPI-PCP-THC
CLINICAL REFERENCE LABORATORY, INC.
50900
Not in Commercial Distribution

  • 81781502509004 ()
50900

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-COC-MET-OPI-OXY-PCP-THC
CLINICAL REFERENCE LABORATORY, INC.
50701
Not in Commercial Distribution

  • 81781502507017 ()
50701

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, BAR-BZO-COC-MET-OPI-PCP-THC
CLINICAL REFERENCE LABORATORY, INC.
50700
Not in Commercial Distribution

  • 81781502507000 ()
50700

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel Cup Drug Test, COC-MET-OPI-PCP-THC
CLINICAL REFERENCE LABORATORY, INC.
50500
Not in Commercial Distribution

  • 81781502505006 ()
50500

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDMA Single Drug Urine Test Panel
Instant Technologies, Inc.
AWDMD-114
In Commercial Distribution

  • 00817405021123 ()
AWDMD-114

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DELTA 1.7MM PANEL 22X22 CTRSINKS X0.5MM
Stryker Leibinger GmbH & Co. KG
70-92052
In Commercial Distribution

  • 07613327090147 ()

  • Thickness: 0.5 Millimeter
  • 3D Plates: 22x22 Holes
70-92052

  • Craniofacial fixation plate, bioabsorbable
Top Sheet W/Clear Panel BNS
Cardinal Health 200, LLC
47187TNS
In Commercial Distribution

  • 50885380022874 ()
  • 10885380022876 ()
47187TNS

  • Patient surgical drape, single-use
CS 7600 SLOT PANEL SIZE 4
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023711 ()
1023712

  • Dental computed radiography digital imaging scanner
CS 7600 SLOT PANEL SIZE 1-3
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971023704 ()
1023704

  • Dental computed radiography digital imaging scanner
Remote Control Panel 6 x 72
MEDICAL TECHNIQUE, INC.
9414-40
In Commercial Distribution

  • 00815384022247 ()
  • 00815384022230 ()
  • 00815384022223 ()
9414-40

  • Instrument/equipment drape, single-use, sterile
KIT, OPTIGEN US Panel Control Reagent
Minaris Medical America, Inc.
80109
In Commercial Distribution

  • 00813382010402 ()
80109

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, control
6 Panel Oral Fluid Test, AMP-BZO-COC-MET-OPI-THC
Express Diagnostic Int'l, Inc.
80600-EI
In Commercial Distribution

  • B29880600EI0 ()
80600-EI

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-PCP-THC
Express Diagnostic Int'l, Inc.
71021
In Commercial Distribution

  • B2987102110 ()
71021

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