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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Six Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: AMP | BZO | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PSC-DOA-264
In Commercial Distribution

  • 00850557007461 ()
  • 00850557007478 ()
  • 10850557007475 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
PS-DOA-854
In Commercial Distribution

  • 00850557007386 ()
  • 00850557007393 ()
  • 10850557007390 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | BZO | COC | OPI | THC
MERGERS MARKETING, INC.
PS-DOA-754
In Commercial Distribution

  • 00850557007362 ()
  • 00850557007379 ()
  • 10850557007376 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: BZO | COC | MET | MOR | THC
MERGERS MARKETING, INC.
PS-DOA-654
In Commercial Distribution

  • 00850557007324 ()
  • 00850557007331 ()
  • 10850557007338 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
The Single Flat Panel Monitor Yoke Assembly is used with the HarmonyAIR E-Series Suspension System.
STERIS CORPORATION
E-Series Suspension System
Not in Commercial Distribution

  • 00724995171759 ()
10100167

  • Medical monitor/light mount
WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & UNDER WORKSURFACE PANEL CONTROL, FOREST GREY
Ls Enterprises, Inc.
2186BC-G
In Commercial Distribution

  • D0692186BCG0 ()


  • Dental delivery system
WORKSURFACE, REAR BENEATH COUNTER W/DUO UNIT LEFT/RIGHT & UNDER WORKSURFACE PANEL CONTROL, DESIGNER FRIENDLY
Ls Enterprises, Inc.
2186BC-C
In Commercial Distribution

  • D0692186BCC0 ()


  • Dental delivery system
10 Panel Drug Test Cup AMP/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-9104
In Commercial Distribution

  • 20817038021341 ()
  • 10817038021344 ()
  • 00817038021347 ()
U-CUP-9104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup AMP/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/THC
UCP BIOSCIENCES, INC.
U-CUP-8104
In Commercial Distribution

  • 20817038021129 ()
  • 10817038021122 ()
  • 00817038021125 ()
U-CUP-8104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Card - CLIA - AMP/THC/COC/OPI/PCP/BZO/BARB/MTD/mAMP/OXY
CONFIRM BIOSCIENCES, INC.
CB-HE-4104
In Commercial Distribution

  • 00895330002783 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Dip Card - CLIA COC,THC,OPI,BZO,mAMP,TCA,OXY,BUP,BAR,MTD
CONFIRM BIOSCIENCES, INC.
CB-HE-7104
In Commercial Distribution

  • 00895330002622 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - 9 Panel Dip Card - AMP1000/BAR300/BZO300/COC300/mAMP1000/MTD300/MOP2000/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-194
In Commercial Distribution

  • 00895330002608 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Methadone IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent
10 Panel DOA Cup (10.46) -OXY100 MDMA500 COC150 BZO300 MTD300 BUP10 MET500 MOR300 AMP500 THC50
BTNX Inc
D10.46-1VF
In Commercial Distribution

  • 00722066009017 ()
  • 10722066009014 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Reusable non-sterile foot panel for use with Calypso 4D Localization System and Varian Exact base
MEDTEC, INC.
20IL430035
Not in Commercial Distribution

  • 00841439102107 ()

  • Length: 120 Centimeter
20IL430035

  • Indexed-immobilization patient positioning system
Reusable non-sterile head panel for use with Calypso 4D Localization System and Varian Exact base
MEDTEC, INC.
20IL430030
Not in Commercial Distribution

  • 00841439102084 ()

  • Length: 56 Centimeter
20IL430030

  • Indexed-immobilization patient positioning system
X-MIND trium PAN version including one PAN sensor, with control panel on the left side
DE GÖTZEN SRL
XMT PAN L
Not in Commercial Distribution

  • D804W09000070 ()
W0900007

  • Stationary panoramic/tomographic dental x-ray system, digital
X-MIND trium PAN version including one PAN sensor,with control panel on the right side
DE GÖTZEN SRL
XMT PAN R
Not in Commercial Distribution

  • D804W09000010 ()
W0900001

  • Stationary panoramic/tomographic dental x-ray system, digital
  • Cone beam computed tomography system, head/neck
BluRapids CLIA Waived Drug Cup; 6 Panel with Adulterants BZO/COC/MET/OPI/OXY/THC
MERCEDES MEDICAL, LLC
TNR CDOA262
In Commercial Distribution

  • 00850011007044 ()
  • 10850011007041 ()
  • 20850011007048 ()
TNR CDOA262

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
QC Sets and Panels: KWIK-STIK™ Blood Culture Identification 2 (BCID2) Verification Panel (Live Culture)
MICROBIOLOGICS INC.
5258P
Not in Commercial Distribution

  • 70845357043282 ()
5258P

  • Multiple bacteria species culture isolate identification control IVD, kit
QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8235
In Commercial Distribution

  • 70845357043084 ()
8235

  • Human papillomavirus (HPV) nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Multi-Strain Human Papillomavirus (HPV) Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8234
In Commercial Distribution

  • 70845357043077 ()
8234

  • Human papillomavirus (HPV) nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8206
In Commercial Distribution

  • 70845357042810 ()
8206

  • Multiple Mycobacterium species nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Group B Streptococcus (GBS) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8232
In Commercial Distribution

  • 70845357042735 ()
8232

  • Beta-haemolytic Group B Streptococcus nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Respiratory Pathogens (16 Strains) Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8198
Not in Commercial Distribution

  • 70845357041455 ()
8198

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Vancomycin Resistant Enterococcus (VRE) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8203
In Commercial Distribution

  • 70845357041387 ()
8203

  • Vancomycin-resistant Enterococcus (VRE) nucleic acid IVD, control
U-Screen Squared Integrated Cup with 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Technologies, Inc.
USSCup-5M
In Commercial Distribution

USSCup-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
8 Panel E&I Oral Click Cube AMP50, BAR50, COC20, MDMA50, MET50, MTD30, OPI40, OXY20
Instant Technologies, Inc.
ABTOFCUBE0801A
In Commercial Distribution

  • 30817405023920 ()
  • 00817405023929 ()
  • 10817405023926 ()
ABTOFCUBE0801A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
9 PANEL E&I OF CUBE AMP50/BAR20/COC20/MDMA50/MET50/MTD30/OPI40/OXY20/PCP10
Instant Technologies, Inc.
ABTOFCUBE0901A
In Commercial Distribution

  • 30817405023562 ()
  • 00817405023561 ()
  • 10817405023568 ()
ABTOFCUBE0901A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL 510(K) SQUARE CUP AMP1000, COC300, MET1000, OPI2000, THC50 SVT (CR,OX,SG)
Instant Technologies, Inc.
ABTDUAK15701A
In Commercial Distribution

  • 30817405023500 ()
  • 00817405023509 ()
  • 10817405023506 ()
ABTDUAK15701A

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
5 PANEL CLIA WAIVED SQUARE CUP AMP500, BZO300, COC150, MET500, MOP300 SVT (CR,pH,S.G.)
Instant Technologies, Inc.
ABTDUAW15702B
In Commercial Distribution

  • 30817405023395 ()
  • 00817405023394 ()
  • 10817405023391 ()
ABTDUAW15702B

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