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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2 Panel Dip Drug Test, COC150-THC
Express Diagnostic Int'l, Inc.
30209
In Commercial Distribution

  • B2983020910 ()
30209

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, COC150-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30209
Not in Commercial Distribution

  • B298302090 ()
30209

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, BUP-PPX
EXPRESS DIAGNOSTICS INT'L, INC.
30207
Not in Commercial Distribution

  • B298302070 ()
30207

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, OPI-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30206
Not in Commercial Distribution

  • B298302060 ()
30206

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, MDMA-PCP
EXPRESS DIAGNOSTICS INT'L, INC.
30204
Not in Commercial Distribution

  • B298302040 ()
30204

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, BUP-MET
EXPRESS DIAGNOSTICS INT'L, INC.
30203
Not in Commercial Distribution

  • B298302030 ()
30203

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, COC-OPI300
EXPRESS DIAGNOSTICS INT'L, INC.
30202
Not in Commercial Distribution

  • B298302020 ()
30202

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, BZO-OXY
EXPRESS DIAGNOSTICS INT'L, INC.
30201
Not in Commercial Distribution

  • B298302010 ()
30201

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, COC-THC
Express Diagnostic Int'l, Inc.
30200
In Commercial Distribution

  • B2983020010 ()
30200

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
2 Panel Dip Drug Test, COC-THC
EXPRESS DIAGNOSTICS INT'L, INC.
30200
Not in Commercial Distribution

  • B298302000 ()
30200

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
Live View Panel Pro Version 2.0
Neurotronics, LLC
2.0
In Commercial Distribution

  • 00817111021264 ()


  • Sleep disorder interpretive software, professional-only
  • Bioelectrical signal analysis software
5 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-654
In Commercial Distribution

  • 20816490023740 ()
  • 10816490023743 ()
  • 00816490023746 ()
HCDOAEW-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-955
In Commercial Distribution

  • 20816490023726 ()
  • 10816490023729 ()
  • 00816490023722 ()
HCDOAEW-955

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-8104
In Commercial Distribution

  • 20816490023023 ()
  • 10816490023026 ()
  • 00816490023029 ()
DOAY-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-654
In Commercial Distribution

  • 20816490023016 ()
  • 10816490023019 ()
  • 00816490023012 ()
DOAY-654

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-3124
In Commercial Distribution

  • 20816490022927 ()
  • 10816490022920 ()
  • 00816490022923 ()
DOAY-3124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-6124
In Commercial Distribution

  • 20816490023467 ()
  • 10816490023460 ()
  • 00816490023463 ()
HCDOAEW-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-4105
In Commercial Distribution

  • 20816490023450 ()
  • 10816490023453 ()
  • 00816490023456 ()
HCDOAEW-4105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-8104
In Commercial Distribution

  • 20816490023382 ()
  • 10816490023385 ()
  • 00816490023388 ()
HCDOAEW-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
13 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-2135
In Commercial Distribution

  • 20816490023344 ()
  • 10816490023347 ()
  • 00816490023340 ()
HCDOAEW-2135

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEW-8105
In Commercial Distribution

  • 20816490023092 ()
  • 10816490023095 ()
  • 00816490023098 ()
HCDOAEW-8105

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-6125
In Commercial Distribution

  • 20816490022996 ()
  • 10816490022999 ()
  • 00816490022992 ()
DOAY-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-6124
In Commercial Distribution

  • 20816490022972 ()
  • 10816490022975 ()
  • 00816490022978 ()
DOAY-6124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-564
In Commercial Distribution

  • 20816490022965 ()
  • 10816490022968 ()
  • 00816490022961 ()
DOAY-564

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-5125
In Commercial Distribution

  • 20816490022958 ()
  • 10816490022951 ()
  • 00816490022954 ()
DOAY-5125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
DOAY-4104
In Commercial Distribution

  • 20816490022934 ()
  • 10816490022937 ()
  • 00816490022930 ()
DOAY-4104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test clear Cup
Healgen Scientific Limited Liability Company
HCDOAEC-6125
In Commercial Distribution

  • 20816490022453 ()
  • 10816490022456 ()
  • 00816490022459 ()
HCDOAEC-6125

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
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
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
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
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
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
Top Sheet W/Clear Panel BNS
Cardinal Health 200, LLC
47187TNS
In Commercial Distribution

  • 50885380022874 ()
  • 10885380022876 ()
47187TNS

  • Patient surgical drape, single-use
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
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
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