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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 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 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
Bionix, LLC
2265
In Commercial Distribution

  • 10859911004754 ()
  • 00859911004757 ()
2265

  • ENT instrument magnifying lens
Replacement magnifier
EAR TECHNOLOGY CORPORATION
LB-Magnifier
In Commercial Distribution

  • 00810323005732 ()


  • ENT instrument magnifying lens
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
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
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
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
The MAGPIX Drive Fluid serves as the delivery medium that carries the sample to the optics component of the MAGPIX instrument.
LUMINEX CORPORATION
MPXDF-4PK-1
In Commercial Distribution

  • 00840487101421 ()


  • Multiplex analyser IVD, laboratory
Reusable device used in the laboratory to replicate in the master model the position of the sphere present in the mouth.
RHEIN 83 SRL
POSITIONING PIVOTS PLAS/MODEL STRATEGYx2
Not in Commercial Distribution

  • D821044PPS0 ()
044PPS

  • Dental implant suprastructure, permanent, preformed
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
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
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
MET1000
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266001055 ()
VC-S01-MET1000-40

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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
AMP 500
Verify Diagnostics Inc
1.0
In Commercial Distribution

  • 00870266000836 ()
VC-S01-AMP-40

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