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

  • 20817038021402 ()
  • 10817038021405 ()
  • 00817038021408 ()
U-BZO-114L

  • Benzodiazepine group IVD, kit, rapid ICT, clinical
u-Card BAR Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-BAR-114L
In Commercial Distribution

  • 20817038021396 ()
  • 10817038021399 ()
  • 00817038021392 ()
U-BAR-114L

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

  • 20817038021389 ()
  • 10817038021382 ()
  • 00817038021385 ()
U-MDMA-114L

  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
u-Card COC Single Panel Dip Test Card
UCP BIOSCIENCES, INC.
U-COC-114L
In Commercial Distribution

  • 10817038021375 ()
  • 00817038021378 ()
  • 20817038021372 ()
U-COC-114L

  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Home Drug Test 2 Panel COC/THC
RITE AID CORPORATION
8024509
In Commercial Distribution

  • 00011822001687 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
4 Panel OralTox - AMP/COC/OPI/PCP
PREMIER BIOTECH, INC
OT80404
Not in Commercial Distribution

  • B313OT804041 ()
  • B3130T804040 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel OralTox - COC/MET/OPI/OXY
PREMIER BIOTECH, INC
OT80402
Not in Commercial Distribution

  • B313OT804021 ()
  • B313OT804020 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
4 Panel OralTox - AMP/COC/OPI/THC
PREMIER BIOTECH, INC
OT80401
Not in Commercial Distribution

  • B313OT804011 ()
  • B313OT804010 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BUP-BZO-COC-MDMA-MTD-OPI300-OXY-PPX-THC-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61093-2
Not in Commercial Distribution

  • B2986109320 ()
61093-2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BUP-BZO-COC-MDMA-MET-MTD-OPI300-OXY-THC-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
61056-2
Not in Commercial Distribution

  • B2986105620 ()
61056-2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Cup Drug Test, AMP-BARB-BZO-COC-MDMA-MET-MTD-OPI-PCP-THC-pH,SG.OX
Express Diagnostic Int'l, Inc.
61025-3
In Commercial Distribution

  • B29861025310 ()
61025-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 Panel Cup Drug Test, AMP-BUP-BZO-COC-MDMA-MTD-OPI300-OXY-THC-CR,NI
EXPRESS DIAGNOSTICS INT'L, INC.
60961-2
Not in Commercial Distribution

  • B2986096120 ()
60961-2

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
7 Panel Cup Drug Test, AMP-BZO-COC-MET-OPI-PCP-THC-pH,SG.OX
Express Diagnostic Int'l, Inc.
60748-3
In Commercial Distribution

  • B29860748310 ()
60748-3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
BD MAX™ Enteric Parasite Control Panel
MICROBIOLOGICS INC.
8204 BD MAX™ Enteric Parasite Control Panel
In Commercial Distribution

  • 70845357041394 ()
8204

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Suspension, Single Universal Flat Panel, Ceiling, 9'
STRYKER COMMUNICATIONS INC.
0682000850
In Commercial Distribution

  • 07613327166736 ()
0682000850

  • Medical monitor/light mount
Suspension, Single Universal Flat Panel, Ceiling, 10'
STRYKER COMMUNICATIONS INC.
0682000852
In Commercial Distribution

  • 07613327166712 ()
0682000852

  • Medical monitor/light mount
CS 7600 SLOT PANEL SIZE 0 ONLY
CARESTREAM HEALTH, INC.
CS 7600 SLOT PANEL
In Commercial Distribution

  • 60889971044440 ()
1044445

  • Dental computed radiography digital imaging scanner
DELTA 1.7MM PANEL 1X21 CTRSINKS X 0.5MM
Stryker Leibinger GmbH & Co. KG
70-92055
In Commercial Distribution

  • 07613327123364 ()

  • Thickness: 0.5 Millimeter
  • 3D Plates: 1x21 Holes
70-92055

  • Craniofacial fixation plate, bioabsorbable
DELTA 1.7MM PANEL 1X21 CTRSINKS X 0.75MM
Stryker Leibinger GmbH & Co. KG
70-92056
In Commercial Distribution

  • 07613327123340 ()

  • 3D Plates: 1x21 Holes
  • Thickness: 0.75 Millimeter
70-92056

  • Craniofacial fixation plate, bioabsorbable
DELTA 2.2MM PANEL 1X21 CTRSINKS X 1.4MM
Stryker Leibinger GmbH & Co. KG
70-92057
In Commercial Distribution

  • 07613327123302 ()

  • 3D Plates: 1x21 Holes
  • Thickness: 1.4 Millimeter
70-92057

  • Craniofacial fixation plate, bioabsorbable
830 Single Panel Knee Immobilizer 24" (XL)
VIVE HEALTH LLC
SUP3019BLK24XL
In Commercial Distribution

  • 10810113570966 ()
  • 00810113570969 ()


  • Knee support orthosis
830 Single Panel Knee Immobilizer 20" (XL)
VIVE HEALTH LLC
SUP3019BLK20XL
In Commercial Distribution

  • 10810113570942 ()
  • 00810113570945 ()


  • Knee support orthosis
830 Single Panel Knee Immobilizer 18" (XL)
VIVE HEALTH LLC
SUP3019BLK18XL
In Commercial Distribution

  • 10810113570935 ()
  • 00810113570938 ()


  • Knee support orthosis
830 Single Panel Knee Immobilizer (XL) 16"
VIVE HEALTH LLC
SUP3019BLK16XL
In Commercial Distribution

  • 10810113570928 ()
  • 00810113570921 ()


  • Knee support orthosis
5 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAEW-254
In Commercial Distribution

  • 20816490022590 ()
  • 10816490022593 ()
  • 00816490022596 ()
HCDOAEW-254

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
12 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOAEW-9125
In Commercial Distribution

  • 20816490022583 ()
  • 10816490022586 ()
  • 00816490022589 ()
HCDOAEW-9125

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

  • 20816490022118 ()
  • 10816490022104 ()
  • 00816490022107 ()
HCDOAF-6124

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

  • 20816490021210 ()
  • 10816490021213 ()
  • 00816490021216 ()
HCDOAF-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel DOA Test Clear Round Cup
Healgen Scientific Limited Liability Company
HCDOA-1104S
In Commercial Distribution

  • 20816490021197 ()
  • 10816490021190 ()
  • 00816490021193 ()
HCDOA-1104S

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

  • 20816490021074 ()
  • 10816490021077 ()
  • 00816490021070 ()
HCDOA-955

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