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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MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution

  • 00860003196991 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution

  • 00860003196953 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup – AMP, BZO, BUP, COC, MET, MTD, MDMA, OPI, OXY, THC
DEUS VULT, LLC
P33-10-MET
Not in Commercial Distribution

  • 00860004081661 ()
  • 00860004081654 ()
  • 00860004081647 ()
P33-10-MET

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Healgen (DrugConfirm) - NO THC + PCP - 5 Panel Clicker Cup Test: AMP1000/COC300/mAMP1000/MOP2000/PCP25
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-253
In Commercial Distribution

  • 00856464008584 ()


  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
5 Multi Drug Test Panel (AMP 1000 • COC 300 • MET 1000 • OPI 2000 • THC 50)
IDUN SOLUTIONS LLC
21115061010308-B
In Commercial Distribution

  • 00857275007438 ()
  • 00857275007537 ()


  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
5 Multi Drug Test Panel (BZO 300 • COC 300 • MET 1000 • MOP 300 • THC 50)
IDUN SOLUTIONS LLC
21505040010308
In Commercial Distribution

  • 00857275007391 ()
  • 00857275007513 ()


  • Cannabinoid/cannabinoid metabolite 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
MDC-994 9 Panel CLIA Waived Cup (COC300/OPI2000/AMP1000/MET1000/PCP25 /BZO300/BAR300/MTD300/OXY100)
Medical Disposables Corp
MDC-994
In Commercial Distribution

  • 00860113002083 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
U-Screen Squared Integrated Cup with 5 Panel Drug Screen for (THC/COC/OPI2000/AMP/MET)
Instant Tech Subsidiary Acquisition
USSCup-5M
Not in Commercial Distribution

  • 00858998006036 ()
USSCup-5M

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
NexScreen Drug Dip Card 9 Panel COC150/THC50/OPI2000/AMP500/MET500/ PCP25/BZO300/BAR300/MTD300
NEXSCREEN, LLC
NCard-12-BUP
In Commercial Distribution

  • 00858984006316 ()
NCard-12-BUP

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
NexScreen Drug Dip Card 9 Panel COC150/THC50/OPI2000/AMP500/MET500/ PCP25/BZO300/BAR300/MTD300
NEXSCREEN, LLC
NCard-09-01
In Commercial Distribution

  • 00858984006309 ()
NCard-09-01

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel Clear Scan Drug Test Cup Drug Combo: BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
CSC-564
In Commercial Distribution

  • 00850557007881 ()
  • 00850557007898 ()
  • 10850557007895 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Six Panel PreScreen Plus Cup (CLIA Waived) Drug Combo: BZO | COC | MET | OPI | OXY | THC
MERGERS MARKETING, INC.
PSC-DOA-564
In Commercial Distribution

  • 00850557007522 ()
  • 00850557007539 ()
  • 10850557007536 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
Five Panel PreScreen Plus Dip Card (CLIA Waived) Drug Combo: AMP | COC | MET | OPI | THC
MERGERS MARKETING, INC.
PS-DOA-254
In Commercial Distribution

  • 00850557007140 ()
  • 00850557007157 ()
  • 10850557007154 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Five Panel PreScreen Plus Mini Cup (CLIA Waived) Drug Combo: COC|AMP|MAMP|THC|OPI
MERGERS MARKETING, INC.
PSC-DOA-254M
In Commercial Distribution

  • 20851000007162 ()
  • 10851000007165 ()
  • 00851000007168 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
ALYON Series Spring Arm, Dual Flat Panel Monitor is used with the ALYON Suspension System
STERIS CORPORATION
ALYON Suspension System
In Commercial Distribution

  • 00724995222468 ()
LYS000005

  • Medical monitor/light mount
ALYON Series Spring Arm, Single Flat Panel Monitor is used with the ALYON Suspension System
STERIS CORPORATION
ALYON Suspension System
In Commercial Distribution

  • 00724995222437 ()
LYS000001

  • Medical monitor/light mount
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
The A-Series Spindle Single Flat Panel Monitor is used with the HarmonyAIR A-Series Suspension System.
STERIS CORPORATION
A-Series Suspension System
In Commercial Distribution

  • 00724995190309 ()
LAS000007

  • Medical monitor/light mount
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
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
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
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
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