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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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Eversense® Adhesive Patches, 30-Pack White - 00817491021304

Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6402-01-300
In Commercial Distribution

  • 00817491021304 ()
  • 00817491021342 ()
FG-6402-01-300

  • Implantable glucose monitoring system

Eversense® Adhesive Patches, 30-Pack Clear - 00817491021298

Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin.
SENSEONICS, INCORPORATED
FG-6401-01-300
In Commercial Distribution

  • 00817491021328 ()
  • 00817491021298 ()
  • 00817491021359 ()
FG-6401-01-300

  • Implantable glucose monitoring system

Magnification Lens - 00859911004757

Magnification Lens
Bionix, LLC
2265
In Commercial Distribution

  • 10859911004754 ()
  • 00859911004757 ()
2265

  • ENT instrument magnifying lens

LightBeam - 00810323005732

Replacement magnifier
EAR TECHNOLOGY CORPORATION
LB-Magnifier
In Commercial Distribution

  • 00810323005732 ()


  • ENT instrument magnifying lens

Scan attachable delivery unit (SL-1800) - 04987669100929

The delivery unit is connected to the Green Laser Photocoagulator GYC-500 to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a green laser beam (532 nm) while observing the patient’s eye with the slit lamp. In order to reduce damages to the ocular media, the optical system that ensures low laser power density on the anterior segment is incorporated. A delivery unit to be attached to an existing slit lamp mounted on an existing motorized optical table. The delivery unit is then connected to the main laser device to comprise the photocoagulation system (with the scan function). NIDEK SL-1800 type is available.
NIDEK CO.,LTD.
17452-0000
In Commercial Distribution

  • 04987669100929 ()


  • General/multiple surgical frequency-doubled solid-state laser system

Scan attachable delivery unit (900BQ) - 04987669100943

The delivery unit is connected to the Green Laser Photocoagulator GYC-500 to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a green laser beam (532 nm) while observing the patient’s eye with the slit lamp. In order to reduce damages to the ocular media, the optical system that ensures low laser power density on the anterior segment is incorporated. A delivery unit to be attached to an existing slit lamp mounted on an existing motorized optical table. The delivery unit is then connected to the main laser device to comprise the photocoagulation system (with the scan function). HAAG 900 BQ type is available.
NIDEK CO.,LTD.
17457-0000
In Commercial Distribution

  • 04987669100943 ()


  • General/multiple surgical frequency-doubled solid-state laser system

Scan attachable delivery unit (SL130) - 04987669100936

The delivery unit is connected to the Green Laser Photocoagulator GYC-500 to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a green laser beam (532 nm) while observing the patient’s eye with the slit lamp. In order to reduce damages to the ocular media, the optical system that ensures low laser power density on the anterior segment is incorporated. A delivery unit to be attached to an existing slit lamp mounted on an existing motorized optical table. The delivery unit is then connected to the main laser device to comprise the photocoagulation system (with the scan function). ZEISS SL130 type is available.
NIDEK CO.,LTD.
17454-0000
In Commercial Distribution

  • 04987669100936 ()


  • General/multiple surgical frequency-doubled solid-state laser system

Scan attachable delivery unit (30SL/M) - 04987669100912

The delivery unit is connected to the Green Laser Photocoagulator GYC-500 to comprise the photocoagulation system and to treat affected areas using a slit lamp. The photocoagulation system enables photocoagulation using a green laser beam (532 nm) while observing the patient’s eye with the slit lamp. In order to reduce damages to the ocular media, the optical system that ensures low laser power density on the anterior segment is incorporated. A delivery unit to be attached to an existing slit lamp mounted on an existing motorized optical table. The delivery unit is then connected to the main laser device to comprise the photocoagulation system (with the scan function). ZEISS 30 SL type is available.
NIDEK CO.,LTD.
17451-0000
In Commercial Distribution

  • 04987669100912 ()


  • General/multiple surgical frequency-doubled solid-state laser system

Walgreens - 00311917034249

14 Drugs Tested Home Drug Test - AMP1000/BAR300/BUP10/BZO300/COC300/MDMA500/MET1000/MTD300/OPI2000/OXY100/PCP25/PPX300/TCA1000/THC50
WALGREEN CO.
765426
In Commercial Distribution

  • 00311917034249 ()
  • 10311917034246 ()


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

Equate - 00194346098101

EQ 14 PANEL DRG TEST
WAL-MART STORES, INC.
663396990
In Commercial Distribution

  • 00194346098101 ()


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

VeriCheck Drug Test Dip - 00870266001123

AMP1000 COC300 MET1000 OPI2000 PCP25
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266001123 ()
VC-D05-002-30

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

VeriCheck Drug Test Dip - 00870266001055

MET1000
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266001055 ()
VC-S01-MET1000-40

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

VeriCheck Drug Test Cup - 00870266001000

AMP500 BAR300 BUP10 BZO300 COC150 EDDP300 MDMA500 MET500 OPI300 OXY100 PCP25 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266001000 ()
VC-C12-010-25

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

VeriCheck Drug Test Dip - 00870266000836

AMP 500
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000836 ()
VC-S01-AMP-40

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

VeriCheck Drug Test Cup - 00870266000737

AMP500 BAR300 BUP10 BZO300 COC150 MET500 MDMA500 OPI300 MTD300 OXY100 PCP25 THC50 CR PH SG
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000737 ()
VC-C12-007-25-SVT3A

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

VeriCheck Drug Test Cup - 00870266000720

AMP500 BAR300 BUP10 BZO300 COC150 MET500 MDMA500 OPI300 MTD300 OXY100 PCP25 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000720 ()
VC-C12-007-25

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

VeriCheck Drug Test Cup - 00870266000706

VeriCheck 12-panel Cup AMP500 BAR300 BZO300 COC150 MDMA500 MET500 MTD300 OPI2000 OXY100 PCP25 PPX300 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000706 ()
VC-C12-005-35

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

VeriCheck Drug Test Cup - 00870266000584

AMP1000 BAR300 BZO300 COC300 MET1000 MTD300 OPI2000 OXY100 PCP25 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000584 ()
VC-C10-002-35

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

VeriCheck Drug Test Cup - 00870266000515

AMP500 COC150 MET500 MDMA500 OPI2000 OXY100 PCP25 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000515 ()
VC-C08-001-35

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

VeriCheck Drug Test Cup - 00870266000508

AMP500 COC150 MET500 MDMA500 OPI2000 PCP25 THC50 CR SG PH NI OX GL
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000508 ()
VC-C07-002-35-SVT6

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

VeriCheck Drug Test Cup - 00870266000492

AMP500 COC150 MET500 MDMA500 OPI2000 PCP25 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000492 ()
VC-C07-001-35

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

VeriCheck Drug Test Cup - 00870266000461

AMP500 COC150 MET500 MDMA500 OPI2000 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000461 ()
VC-C06-001-35

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

VeriCheck Drug Test Cup - 00870266000423

AMP1000 COC300 MET1000 OPI2000 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000423 ()
VC-C05-002-35

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

VeriCheck Drug Test Cup - 00870266000416

AMP1000 COC300 OPI2000 PCP25 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000416 ()
VC-C05-001-35

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

VeriCheck Drug Test Dip - 00870266000393

AMP500 BAR300 BZO300 COC150 MTD300 MDMA500 MET500 OPI2000 OXY100 PCP25 PPX300 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000393 ()
VC-D12-005-37

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

VeriCheck Drug Test Dip - 00870266000270

AMP500 COC150 MET500 MDMA500 OPI2000 OXY100 PCP25 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000270 ()
VC-D08-001-30

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

VeriCheck Drug Test Dip - 00870266000195

AMP1000 COC300 OPI2000 PCP25 THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000195 ()
VC-D05-001-30

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

VeriCheck Drug Test Dip - 00870266000126

CLIA Waived Drug Test Dip - 1 Panel BUP10
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000126 ()
VC-D01-BUP10-37

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

VeriCheck Drug Test Dip - 00870266000089

CLIA Waived Drug Test Dip - 1 Panel OXY100
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000089 ()
VC-D01-OXY100-37

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

VeriCheck Drug Test Dip - 00870266000072

COC 150
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000072 ()
VC-D01-COC150-37

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

VeriCheck Drug Test Dip - 00870266000065

Opiates (300)
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000065 ()
VC-D01-OPI300-37

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

VeriCheck Drug Test Dip - 00870266000034

CLIA Waived Drug Test Dip - 1 Panel THC50
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000034 ()
VC-D01-THC50-37

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

VeriCheck Drug Test Dip - 00870266000010

MET500
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000010 ()
VC-S01-MET500-40

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

EZCHECK - 00850065976600

EZCHECK® Multi-Drug Urine Test Clicker Cup, 14-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
EZTDOA-1144
In Commercial Distribution

  • 30850065976601 ()
  • 00850065976600 ()


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

EZCHECK - 00850065976594

EZCHECK® Multi-Drug Urine Test Dipcard, 6-Panel, 5T/Box
Guangzhou Decheng Biotechnology Co., LTD
EZDOA-264
In Commercial Distribution

  • 30850065976595 ()
  • 00850065976594 ()


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

NOBLE - 00850065976563

NOBLE Multi-Drug Urine Test Cup, 7-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
NMCup-07-40-DK
In Commercial Distribution

  • 30850065976564 ()
  • 00850065976563 ()


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

NOBLE - 00850065976556

NOBLE Multi-Drug Urine Test Dipcard, 7-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
NMCardA-07-34-DK
In Commercial Distribution

  • 30850065976557 ()
  • 00850065976556 ()


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

Amazewell - 00850065976518

Amazewell™ Multi-Drug Urine Test Dipcard, 10-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
AFD-4104
In Commercial Distribution

  • 30850065976519 ()
  • 00850065976518 ()


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

Amazewell - 00850065976501

Amazewell™ Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
AFD-6124
In Commercial Distribution

  • 30850065976502 ()
  • 00850065976501 ()


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

Amazewell - 00850065976495

Amazewell™ Multi-Drug Urine Test Dipcard, 12-Panel, 25T/Box
Guangzhou Decheng Biotechnology Co., LTD
AFD-6125
In Commercial Distribution

  • 30850065976496 ()
  • 00850065976495 ()


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