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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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CUSA® Selector® - 10381780040361

The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy. The Tips deliver the mechanical motion to ablate the tissues then aspirate the waste fluid and suspended tissue pieces. The Flues are hollow cones. The Flues are intended to direct the saline irrigation fluid to the site of operation. They are manufactured from clear plastic.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523235
Not in Commercial Distribution

  • 30381780040365 ()
  • 10381780040361 ()
  • M26915232351 ()

  • 35kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

CUSA® Selector® - 10381780122005

The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy. The Tips deliver the mechanical motion to ablate the tissues then aspirate the waste fluid and suspended tissue pieces. The Flues are hollow cones. The Flues are intended to direct the saline irrigation fluid to the site of operation. They are manufactured from clear plastic.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1529165
Not in Commercial Distribution

  • 30381780122009 ()
  • 10381780122005 ()
  • M26915291651 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

CUSA® Selector® - 10381780121978

The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy. The Tips deliver the mechanical motion to ablate the tissues then aspirate the waste fluid and suspended tissue pieces. The Flues are hollow cones. The Flues are intended to direct the saline irrigation fluid to the site of operation. They are manufactured from clear plastic.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523215
Not in Commercial Distribution

  • 30381780121972 ()
  • 10381780121978 ()
  • M26915232151 ()

  • 24kHz Ultrasonic Frequency


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

Pocguide Multi-Drug Test Panel - 06978151200010

Pocguide Multi-Drug Test Panel (CLIA Waived), 12-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/MET500/MDMA500/MTD300/MOP300/OXY100/PCP25/THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200010 ()


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

Pocguide Multi-Drug Test Cup - 06978151200003

Pocguide Multi-Drug Test Cup (CLIA Waived), 12-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/MET500/MDMA500/MTD300/MOP300/OXY100/PCP25/THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200003 ()


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

AssureTech Quick Cup Test - 06952804802653

12 strips, including MOR2000
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802653 ()


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

AssureTech Panel Dip Tests - 06952804802646

12 Strips, including MOR2000
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804802646 ()


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

AssureTech Panel Dip Tests - 06952804801656

No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801656 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical

AssureTech Quick Cup Test - 06952804801649

No Description
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804801649 ()


  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical

Multi-Drug 13 Drugs Rapid Test Cup - 06936983165419

FDA Clia Waived, AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/FYL1
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 16936983165416 ()
  • 06936983165419 ()


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

Healgen (Private Label) - 6114 - 00856464008393

Healgen (DrugConfirm) - 11 Panel Cup Test: AMP1000/BAR300/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP31-6114
In Commercial Distribution

  • 00856464008393 ()


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

Rapid Response - 10722066007553

10 Panel One Step DOA Cup(10.3) - COC300 AMP1000 MET1000 THC50 OPI2000 PCP25 BAR300 BZO300 MTD300 MDMA500
BTNX Inc
D10.3-1VF
In Commercial Distribution

  • 00722066007556 ()
  • 10722066007553 ()


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

Rapid Response - 10722066005672

One Step 12 Panel DOA Cup (12.5.1) - AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25 pH/CRE/SG.
BTNX Inc
D12.5.1-1VA
In Commercial Distribution

  • 00722066005675 ()
  • 10722066005672 ()


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

Healgen (Private Label) 6125A3 - 00895330002851

Healgen (DrugConfirm) - 12 Panel AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/THC50/Adulterants (CR/SG/OX)
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-6125A3C
In Commercial Distribution

  • 00895330002851 ()


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

Healgen (Private Label) - 3104 - 00895330002776

Healgen (DrugConfirm) - 10 Panel Dip Card - CLIA - AMP1000/BAR300/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-3104
In Commercial Distribution

  • 00895330002776 ()


  • 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

Healgen (Private Label) - 3104C - 00895330002769

Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP1000/BAR300/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-3104
In Commercial Distribution

  • 00895330002769 ()


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

Healgen (Private Label) - 6125C - 00895330002691

Healgen (DrugConfirm) - 12-panel CLIA Cup AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/THC50/Adulterants (CR/SG/OX)
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-6125
In Commercial Distribution

  • 00895330002691 ()


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

Healgen (Private Label) - 6125 - 00895330002639

Healgen (DrugConfirm) - 12 Panel CLIA Dip Card AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MOP300/MTD300/OXY100/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-6125
In Commercial Distribution

  • 00895330002639 ()


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

Healgen (Private Label) - 6124 - 00895330002615

Healgen (DrugConfirm) - 12 Panel Dip Card CLIA AMP1000/BAR300/BUP10/BZO300/COC300/THC50/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/PCP25
CONFIRM BIOSCIENCES, INC.
CB-HE-9124
In Commercial Distribution

  • 00895330002615 ()


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

Healgen (Private Label) - 194 - 00895330002608

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

Healgen (Private Label) - 6124 - 00895330002561

Healgen (DrugConfirm) - 12 Panel Clicker Cup Test: AMP1000/BAR300/BUP10/BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/PCP25/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-6124
In Commercial Distribution

  • 00895330002561 ()


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

U-Catch - 06972428160793

No Description
Shenzhen Bioeasy Biotechnology Co., Ltd
U-Catch PLUS Multi-Drug Test Cup
In Commercial Distribution

  • 06972428160793 ()
YRLG02701005

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

Discover Multi-Drug 12 Drugs Rapid Test Cup (Urine) - 16936983165713

FDA Clia Waived, MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MTD300/BAR300/BZO300/AMP500/MET500/THC50/BUP10
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983165716 ()
  • 16936983165713 ()


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

Rapid Response - 00722066004913

10 Panel One Step DOA Cup(10.3.1) - COC150 AMP500 MET500 THC50 MOP2000 PCP25 BAR300 BZO300 MTD300 MDMA500
BTNX Inc
D10.3.1-1V
In Commercial Distribution

  • 00722066004913 ()


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

Rapid Response - 00722066004586

10 Panel One Step DOA Cup(10.3) - COC300 AMP1000 MET1000 THC50 OPI2000 PCP25 BAR300 BZO300 MTD300 MDMA500
BTNX Inc
D10.3-1V
In Commercial Distribution

  • 00722066004586 ()


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

Rapid Response One Step DOA Cup - 00722066004500

No Description
BTNX Inc
D10.14-1V
In Commercial Distribution

  • 00722066004500 ()
  • 00722066004517 ()
  • 10722066004514 ()


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

Certa Dose PALS Syringe Holder - 00860425001620

A small device intended to be used to clip to the syringe used to withdraw the medication it contained, during the administration of medication to a patient, in order to identify the type of medication in the syringe to help prevent the misadministration of the medication. It is made of plastic material and designed to be clipped to the base of either a Luer or a Luer-lock syringe. It is typically used by ambulance paramedics, personnel in accident and emergency (A&E) rooms. This is a single-use device
CD Acquisitions, LLC
CD-PALS-0001
In Commercial Distribution

  • 00860425001620 ()
  • 00860425001651 ()
  • 10860425001658 ()


  • Syringe/ampule clip

Clever Choice - 00898302140117

SDI-1586W Automatic Blood Pressure Monitor. Wrist testing site. Also measures heart rate. Displays Blood Pressure reading as well as a World Health Organization rating of Blood Pressure readings, to easily indicate to user whether their blood pressure is too high or too low, and gives the user an idea of by how much. Speaks to the user in English or Spanish
SIMPLE DIAGNOSTICS INC
SDI-1586W
In Commercial Distribution

  • 10898302140114 ()
  • 00898302140117 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Clever Choice - 00898302001357

Automatic Blood Pressure Monitor. Arm testing site. Also measures heart rate. Displays Blood Pressure reading as well as a World Health Organization rating of Blood Pressure readings, to easily indicate to user whether their blood pressure is too high or too low, and gives the user an idea of by how much. Speaks to the user in English or Spanish
SIMPLE DIAGNOSTICS INC
SDI-1886 BPM - Talking
In Commercial Distribution

  • 10898302001354 ()
  • 00898302001357 ()
98302-0148-12

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

CUSA® Selector® - 10381780040415

Selector Wrench Set : The Selector Wrench Set consists of a stainless steel holder and spanner, connected by a chain. The Wrench set is used to assemble the handpiece and tip, and to change tips in the sterile field. The Wrench Set is also used to disassemble the handpiece for cleaning and sterilization. The cut-outs in the holder are sized according to its use with specific handpieces.The wrench sets are required to ensure the tips are attached to the hand pieces correctly.
INTEGRA LIFESCIENCES (IRELAND) LIMITED
1523072M3
In Commercial Distribution

  • 10381780040415 ()


  • Ultrasonic surgical system torque wrench, single-use
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