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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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Piccolo Composite Nailing System - 07290110200862

Connects the Piccolo Composite Ankle Arthrodesis Nailing System Handle to the Nail.
CARBOFIX ORTHOPEDICS LTD
Arthrodesis Nail Adapter
In Commercial Distribution

  • 07290110200862 ()
PFT910110

  • Orthopaedic implant aiming arm

CureWrap™ - 07290107580687

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Pediatric 122-135cm (single )
Not in Commercial Distribution

  • 07290107580687 ()
  • 17290107580684 ()
500-T3548

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ - 07290107580670

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Pediatric 104-122cm (single)
Not in Commercial Distribution

  • 07290107580670 ()
  • 17290107580677 ()
500-T3541

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ - 07290107580663

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Pediatric 91-104cm (single)
Not in Commercial Distribution

  • 07290107580663 ()
  • 17290107580660 ()
500-T3536

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ - 07290107580656

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Pediatric 79-91cm (single)
Not in Commercial Distribution

  • 07290107580656 ()
  • 17290107580653 ()
500-T3531

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ - 07290107580649

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Infant 7-21Kg (single)
Not in Commercial Distribution

  • 07290107580649 ()
  • 17290107580646 ()
500-T3525

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ - 07290107580632

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Infant 4-7Kg (single)
Not in Commercial Distribution

  • 07290107580632 ()
  • 17290107580639 ()
500-T3521

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ - 07290107580625

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Infant (single)
In Commercial Distribution

  • 07290107580625 ()
  • 17290107580622 ()
500-T3518

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ - 07290107580618

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Adult (single)
Not in Commercial Distribution

  • 07290107580618 ()
  • 17290107580615 ()
500-T3500

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ - 07290107580267

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
X-Large Pediatric over 135cm (single)
Not in Commercial Distribution

  • 77290107580266 ()
  • 07290107580267 ()
PED-X2001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ - 07290107580243

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
X-Large Pediatric 122-135 cm (single)
Not in Commercial Distribution

  • 77290107580242 ()
  • 07290107580243 ()
PED-X1001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ - 07290107580113

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Pediatric 104-122 cm (single)
Not in Commercial Distribution

  • 07290107580113 ()
  • 17290107580134 ()
  • 77290107580112 ()
PED-S2001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ - 07290107580090

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Pediatric up to 4K (single)
Not in Commercial Distribution

  • 07290107580090 ()
  • 77290107580099 ()
PED-S1001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

CureWrap™ Adult Over 135 cm - 07290012127175

Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
500-03500
In Commercial Distribution

  • 07290012127175 ()
  • 17290012127172 ()
  • 77290012127174 ()
500-03500

  • External circulating-fluid core temperature regulation system control unit, heating/cooling

Compower - 06946430423313

Headgear is designed to fit the mask over the patient 's hand.
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
CP611002
In Commercial Distribution

  • 16946430423310 ()
  • 06946430423313 ()


  • Anaesthesia mask strap, single-use

Multi-Drug 14 Drugs Rapid Test Cup - 06936983165525

FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1)+(OXI/CRE/pH)
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 16936983165522 ()
  • 06936983165525 ()


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

Multi-Drug 14 Drugs Rapid Test Cup - 06936983165471

FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 16936983165478 ()
  • 06936983165471 ()


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

Alltest Multi-Drug 14 Drugs Rapid Test Cup - 06936983165457

FDA Clia Waived, AMP500/BAR300/BZO300/BUP10/COC150/THC50/MTD300/MET500/MDMA500/MOP300/PCP25/TCA1000/OXY100/FYL1
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 16936983165454 ()
  • 06936983165457 ()


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

Equate - 00681131089869

EQ 12 PANEL DRG TEST
WAL-MART STORES, INC.
572627460
In Commercial Distribution

  • 00681131089869 ()


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

Rapid Response - 10722066009076

D13.5-1V- OPI300 MDMA500 OXY100 PCP25 MTD300 BAR300 BZO300 COC150 AMP500 MET500 THC50 BUP10 FYL1
BTNX Inc
D13.5-1V
In Commercial Distribution

  • 00722066009079 ()
  • 10722066009076 ()


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

Rapid Response - 10722066005368

Rapid Response Multi Drug Test Panels (COC/AMP/MET/MDMA/THC/MTD/MOPI/OXY/BAR/BZO/PCP/PPX) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Barbiturates, Benzodiazepines, Cocaine, THC, Phencyclidine and Propoxyphene metabolites in urine.
BTNX Inc
D12.8.1-1P29-25
In Commercial Distribution

  • 00722066005361 ()
  • 10722066005368 ()


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

Healgen (Private Label) - 1125SA3C - 00895330002578

Healgen (DrugConfirm) - 12-panel Clicker Cup Test with Low Cutoff: AMP500/BAR300/BZO300/COC150/mAMP500/MDMA500/MOP300/MTD300/OXY100/PCP25/PPX300/THC50/ Adulterants (CR/SG/OX)
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-1125SA3C
In Commercial Distribution

  • 00895330002578 ()


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

Healgen (Private Label) - 3124 - 00895330002547

Healgen (DrugConfirm) - 12 Panel Clicker Cup Test: AMP1000/BAR300/BUP10/BZO300/COC300/MDMA500/MTD300/MOP2000/OXY100/PCP25/TCA1000/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-3124
In Commercial Distribution

  • 00895330002547 ()


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

Precision DX - 00840050512920

No Description
AMERICAN SCREENING, L.L.C.
PREDX-DOA-764N
In Commercial Distribution

  • 00840050512920 ()


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

CRL STAT Dip Card - 00817815021447

CRL STAT 12 Panel Dip -KCUR920124 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920124
In Commercial Distribution

  • 00817815021447 ()


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

CRL STAT Dip Card - 00817815021140

CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 & (pH/SG/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920084
In Commercial Distribution

  • 00817815021140 ()


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

CRL STAT Cup - 00817815020877

CRL STAT 11 Panel Cup- KCUR920082 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 (pH/SG/OX/CR/NI)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920082
In Commercial Distribution

  • 00817815020877 ()


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

CRL STAT Dip Card - 00817815020785

CRL STAT 12 Panel Dip -KCUR920124 AMP1000/BAR300/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50
CLINICAL REFERENCE LABORATORY, INC.
KCUR920124
In Commercial Distribution

  • 00817815020778 ()
  • 00817815020785 ()


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

CRL STAT Dip Card - 00817815020709

CRL STAT 11 panel Dip - KCUR920084 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/THC50 & (pH/SG/OX)
CLINICAL REFERENCE LABORATORY, INC.
KCUR920084
In Commercial Distribution

  • 00817815020693 ()
  • 00817815020709 ()


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

Pocguide Multi-Drug Test Panel - 06978151200058

Pocguide Multi-Drug Test Panel (CLIA Waived), 14-Panel, 25T/Box; AMP1000/BAR300/BUP10/BZO300/COC300/EDDP300/MET1000/MDMA500/OPI2000/MTD300/OXY100/PCP25/TCA1000/THC50THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200058 ()


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

Pocguide Multi-Drug Test Cup - 06978151200041

Pocguide Multi-Drug Test Cup (CLIA Waived), 14-Panel, 25T/Box; AMP1000/BAR300/BUP10/BZO300/COC300/EDDP300/MET1000/MDMA500/OPI2000/MTD300/OXY100/PCP25/TCA1000/THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200041 ()


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

Pocguide Multi-Drug Test Panel - 06978151200034

Pocguide Multi-Drug Test Panel (CLIA Waived), 14-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MET500/MDMA500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200034 ()


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

Pocguide Multi-Drug Test Cup - 06978151200027

Pocguide Multi-Drug Test Cup (CLIA Waived), 14-Panel, 25T/Box; AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MET500/MDMA500/MOP300/MTD300/OXY100/PCP25/TCA1000/THC50
Hangzhou Aichek Medical Technology Co., Ltd.
1
In Commercial Distribution

  • 06978151200027 ()


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

U-Catch XR Multi-Drug Test Cup(Colloidal Gold) - 06977469280189

25 Tests/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC,CR,PH,SG
Eterbio, Inc.
ETG011025
In Commercial Distribution

  • 06977469280189 ()


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

U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) - 06977469280042

25 Tests/Kit;12 Panel;AMP;BAR;BUP;BZO;COC;MDMA;MET;MOP;MTD;OXY;PCP;THC;CR;PH;SG
Eterbio, Inc.
ETG004025
In Commercial Distribution

  • 06977469280042 ()


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

U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) - 06977469280011

1 Test/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
Eterbio, Inc.
ETG004001
In Commercial Distribution

  • 06977469280011 ()


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

U-Catch PLUS Multi-Drug Test Cup(Colloidal Gold) - 06977469280004

5 Tests/Kit;12 Panel;AMP,BAR,BUP,BZO,COC,MDMA,MET,MOP,MTD,OXY,PCP,THC
Eterbio, Inc.
ETG004005
In Commercial Distribution

  • 06977469280004 ()


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

AssureTech Quick Cup Tests - 06952804830229

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

  • 06952804830229 ()


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

AssureTech Panel Dip Tests - 06952804830212

AMP500, THC50, COC150, MET500, MOR300, BZO300, OXY100, BAR300, BUP10, MDMA500, PCP25, MTD300, EDDP300, TCA1000, PPX300
ASSURE TECH. (HANGZHOU) CO., LTD.
1.0
In Commercial Distribution

  • 06952804830212 ()


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

Precision DX Multi-Panel Drug Test Card - 16936983167618

MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/THC50
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983167611 ()
  • 16936983167618 ()


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

Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine) - 16936983165720

FDA Clia Waived, MOP(OPI)300/MDMA500/OXY100/PCP25/COC150/MET500/MTD300/BAR300/BZO300/AMP500/TCA1000/THC50/BUP10
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983165723 ()
  • 16936983165720 ()


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

U-Catch - 06972428160786

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

  • 06972428160786 ()
YRLG02801005

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

U-Catch - 06972428161790

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

  • 06972428161790 ()
BXU4105-A3(4)

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

U-Catch - 06972428161738

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

  • 06972428161738 ()
BPU6125-A3(1)

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

U-Catch - 06972428161691

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

  • 06972428161691 ()


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

U-Catch - 06972428161363

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

  • 06972428161363 ()
BXU6125

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

U-Catch - 06972428161110

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

  • 06972428161110 ()
YRLG02801025-3

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

L-Cup - 00722066006740

L-Cup Home Rapid Test (Urine). For the rapid detection of the following drugs in human urine: AMP500 BAR300 BUP10 BZO300 COC150 MDMA500 MTD300 MET500 MOP2000 OXY100 THC50 PCP25
BTNX Inc
D12.5.1-1VL
In Commercial Distribution

  • 10722066006747 ()
  • 00722066006740 ()
  • 20722066006744 ()


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

Rapid Response - 00722066004890

One Step 10 Panel DOA Cup (10.14.1) - COC150 AMP500 MET500 THC50 MTD300 MOP2000 OXY100 PCP25 BAR300 BZO300
BTNX Inc
D10.14.1-1V
In Commercial Distribution

  • 00722066004890 ()


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

Rapid Response - 00722066004876

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

  • 00722066004876 ()


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