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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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HarmonyAIR - 00724995191382

The M5, Single Package with Single Flat Panel Monitor Mount, No Hub, Tandem is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191382 ()
LM04T

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995191375

The M5, Single Package with Single Flat Panel Monitor Mount, without Hub Spacer is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995191375 ()
LM04

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

HarmonyAIR - 00724995190460

The M7 Single Package with Single High Density Flat Panel Monitor with Hub is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995190460 ()
LM29N

  • Operating room light
  • Medical monitor/light mount
  • Operating room light system

u-Cup - 10817038021412

10 Panel Drug Test Cup BAR/BUP/BZO/COC/MET/MTD/OPI/OXY/TCA/THC with Adulteration strip(S.G.,CRE, pH)
UCP BIOSCIENCES, INC.
U-DUD-7104
In Commercial Distribution

  • 20817038021419 ()
  • 10817038021412 ()
  • 00817038021415 ()
U-DUD-7104

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

iScreen™ - 10817405021328

iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/TCA/THC)
Instant Technologies, Inc.
IS12BUP-DX2
In Commercial Distribution

  • 00817405021321 ()
  • 10817405021328 ()
IS12BUP-DX2

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

iScreen™ - 10817405021311

iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/TCA/THC)
Instant Technologies, Inc.
IS12-DX2
In Commercial Distribution

  • 00817405021314 ()
  • 10817405021311 ()
IS12-DX2

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

Platinum+ - 00850011007570

Platinum+ Click Cap Drug Cup, 12 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/THC, CLIA WAIVED
MERCEDES MEDICAL, LLC
MER MMDOAY6125
In Commercial Distribution

  • 10850011007720 ()
  • 00850011007723 ()
  • 00850011007570 ()
MER MMDOAY6125

  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Morphine/morphine metabolite IVD, kit, rapid ICT, clinical
  • Oxycodone IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical

Platinum+ - 00850011007310

Platinum+ Click Cap Drug Cup, 12 Panel, AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/PCP/THC, CLIA WAIVED
MERCEDES MEDICAL, LLC
MER HCDOAY6125
In Commercial Distribution

  • 00850011007334 ()
  • 00850011007327 ()
  • 00850011007310 ()
MER HCDOAY6125

  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) 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
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Buprenorphine IVD, kit, enzyme immunoassay (EIA)
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical

T2Bacteria® Cartridge Kit - M70890080710

The T2Bacteria Cartridge components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Bacteria panel.
T2 BIOSYSTEMS, INC.
90-08071
In Commercial Distribution

  • M70890080710 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

OEC - 00618125190775

Kit, OEC MiniView C-Arm with 15cm FPD (Flat Panel Detector), Drape and Foot Switch Cover. Intended For Use With: OEC MiniView
TIDI PRODUCTS, LLC
31046
In Commercial Distribution

  • 10618125190789 ()
  • 00618125190775 ()
8849777

  • Medical equipment/instrument drape, single-use

X-MIND trium - D804W09002320

X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the left and ceph arm on the left
DE GÖTZEN SRL
XMT PAN L CEPH L
Not in Commercial Distribution

  • D804W09002320 ()
W0900232

  • Stationary panoramic/tomographic dental x-ray system, digital

X-MIND trium - D804W09000090

X-MIND trium PAN_CEPH version including one removable ceph sensor, with control panel on the left and ceph arm on the right
DE GÖTZEN SRL
XMT PAN L CEPH R
Not in Commercial Distribution

  • D804W09000090 ()
W0900009

  • Stationary panoramic/tomographic dental x-ray system, digital

Healgen (Private Label) - 1145 - 00895330002592

Healgen (DrugConfirm) - 14 Panel Clicker Cup Test: AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/PPX300/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-1145
In Commercial Distribution

  • 00895330002592 ()


  • Buprenorphine IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Nortriptyline IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Phencyclidine (PCP) IVD, reagent
  • Propoxyphene/propoxyphene metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, reagent
  • Methadone IVD, reagent

Identify Health Drug Screen Test Cup - 10850013036001

Identify Health 6 Panel Drug Screen Test Cup - CLIA Waived AMP500, COC150, MET500, OPI300, PCP25 THC50 3mm Strip - 25 Pack Box
MEDICAL DISTRIBUTION GROUP INC
ID-H6-3-AZ25
In Commercial Distribution

  • 00850013036004 ()
  • 10850013036001 ()
ID-H6-3-AZ25

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

Identify Diagnostics USA - 10850013035141

(Identify USA - Drug Test Cups) / 6 Panel CLIA Waived Cup - BUP10, BZO300, COC150, MTD300, MOR300, OXY100 3mm Strip - 25 Pack Box
MEDICAL DISTRIBUTION GROUP INC
ID-US6-BUP
In Commercial Distribution

  • 00850013035144 ()
  • 10850013035141 ()
ID-US6-BUP

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

Identify® Diagnostics Drug Test Cards - 10850721007683

Identify® Diagnostics Drug Test Cards 10 Panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ10
In Commercial Distribution

  • 20850721007680 ()
  • 10850721007683 ()
  • 00850721007686 ()
ID-CP10-DIP-AZ10

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

UCP Home TM Drug Screening Test Cards - 10850721007522

UCP Home TM Drug Screening Test Cards 9 Panel Drug Test Card AMP/BUP/BZO/COC/mAMP/MOP/MTD/OXY/THC
MEDICAL DISTRIBUTION GROUP INC
UCP9-DIP-B-394
In Commercial Distribution

  • 20850721007529 ()
  • 10850721007522 ()
  • 00850721007525 ()
UCP9-DIP-B-394

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

Identify® Diagnostics Drug Test Cards - 10850721007492

Identify® Diagnostics Drug Test Cards 10 panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ25
In Commercial Distribution

  • 20850721007499 ()
  • 10850721007492 ()
  • 00850721007495 ()
ID-CP10-DIP-AZ25

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

Identify® Diagnostics Drug Test Cards - 10850721007485

Identify® Diagnostics Drug Test Cards 10 panel Drug Test Card THC/COC/MOP/OXY/MDMA/AMP/BAR/BZO/MET/MTD
MEDICAL DISTRIBUTION GROUP INC
ID-CP10-DIP-AZ5
In Commercial Distribution

  • 20850721007482 ()
  • 10850721007485 ()
  • 00850721007488 ()
ID-CP10-DIP-AZ5

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

Rapid Response - 10722066008253

Rapid Response Single/Multi DOA Panel MOR 2000 (Urine)- OXY100, MDMA500, COC300, BZO300, EDDP300, BUP10, MET1000, OPI2000, AMP1000, THC50-25 tests/ kit
BTNX Inc
D10.43-1P29-25
In Commercial Distribution

  • 00722066008256 ()
  • 10722066008253 ()


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