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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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Rapid Response - 10722066008857

D9.28-1VF- MTD300 EDDP300 MOP300 BUP10 BZO300 COC300 AMP1000 BAR300 THC50
BTNX Inc
D9.28-1VF
In Commercial Distribution

  • 00722066008850 ()
  • 10722066008857 ()


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

Healgen (Private Label) - 8104C - 00895330002677

Healgen (DrugConfirm) - 10 Panel CLIA Cup AMP1000/BUP10/ BZO300/COC300/mAMP1000/MDMA500/MTD300/MOP2000/OXY100/THC50
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-8104
In Commercial Distribution

  • 00895330002677 ()


  • Amphetamine/methamphetamine group 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
  • Opiate/opiate metabolite IVD, reagent
  • Oxycodone IVD, reagent
  • Cannabinoid/cannabinoid metabolite IVD, reagent

iScreen™ - 00817405023349

10 PNL CLIA WAIVED SQUARE CUP AMP1000, BUP10, BZO300, COC300, MDMA500, MET1000, MOP300, MTD300, OXY100, THC50 SVT (CR,OX,S.G.)
Instant Technologies, Inc.
ABTDUAW110703C
In Commercial Distribution

  • 30817405023340 ()
  • 00817405023349 ()
  • 10817405023346 ()
ABTDUAW110703C

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

UScreen® - 00817405021215

U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,OX) 10 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BZO/BUP/MDMA/MTD/OXY)
Instant Technologies, Inc.
USSCupA-10MOB-300CLIA
In Commercial Distribution

USSCUPA-10MOB-3

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

U-Catch - 06972428161783

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

  • 06972428161783 ()
BXU8104-A3(4)

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

U-Catch - 06972428161769

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

  • 06972428161769 ()
BXU8104-A3(1)

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

U-Catch - 06972428161356

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

  • 06972428161356 ()
BXU8104

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

Discover Multi-Drug 9 Drugs Rapid Test Cup(Urine) - 16936983179987

MOP(OPI)300/OXY100/COC150/MET500/MTD300/BZO300/AMP500/THC50/BUP10, 25T, FDA CLIA WAIVED
Hangzhou AllTest Biotech Co., Ltd.
1
In Commercial Distribution

  • 06936983179980 ()
  • 16936983179987 ()


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

Rapid Response - 00722066004678

One Step 9 Panel DOA Cup(9.11) - AMP1000, BUP10, BZO300, COC300, MTD300, MET1000, OPI2000, OXY100, THC50
BTNX Inc
D9.11-1V
In Commercial Distribution

  • 00722066004678 ()


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

AUVON - 06971292002499

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1548
In Commercial Distribution

  • 16971292002496 ()
  • 06971292002499 ()


  • Transcutaneous electrical stimulation electrode, single-use

AUVON - 06971292002482

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1548
In Commercial Distribution

  • 16971292002489 ()
  • 06971292002482 ()


  • Transcutaneous electrical stimulation electrode, single-use

AUVON - 06971292002475

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1P20
In Commercial Distribution

  • 16971292002472 ()
  • 06971292002475 ()


  • Transcutaneous electrical stimulation electrode, single-use

AUVON - 06971292006947

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1548
In Commercial Distribution

  • 16971292006944 ()
  • 06971292006947 ()


  • Transcutaneous electrical stimulation electrode, single-use

AUVON - 06971292006930

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1548
In Commercial Distribution

  • 16971292006937 ()
  • 06971292006930 ()


  • Transcutaneous electrical stimulation electrode, single-use

AUVON - 06971292006886

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1520
In Commercial Distribution

  • 16971292006883 ()
  • 06971292006886 ()


  • Transcutaneous electrical stimulation electrode, single-use

AUVON - 06971292006879

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1520
In Commercial Distribution

  • 16971292006876 ()
  • 06971292006879 ()


  • Transcutaneous electrical stimulation electrode, single-use

AUVON - 06971292006817

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1548
In Commercial Distribution

  • 16971292006814 ()
  • 06971292006817 ()


  • Transcutaneous electrical stimulation electrode, single-use

AUVON - 06971292006763

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1520
In Commercial Distribution

  • 16971292006760 ()
  • 06971292006763 ()


  • Transcutaneous electrical stimulation electrode, single-use

AUVON - 06971292006756

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
EB1520
In Commercial Distribution

  • 16971292006753 ()
  • 06971292006756 ()


  • Transcutaneous electrical stimulation electrode, single-use

AUVON - 06971292002512

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
JJ5010
In Commercial Distribution

  • 16971292002519 ()
  • 06971292002512 ()


  • Transcutaneous electrical stimulation electrode, single-use

AUVON - 06971292002505

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
Shenzhen Yuwen E-Commerce Co., Ltd.
JJ5050
In Commercial Distribution

  • 16971292002502 ()
  • 06971292002505 ()


  • Transcutaneous electrical stimulation electrode, single-use

Del Medical/Universal - 00858340006288

An x-ray system component intended to be mounted to the ceiling, to support and facilitate position of the x-ray tube. The OTC18M does not allow for synchronized tracking or stitching.
Del Medical, Inc.
OTC18M
In Commercial Distribution

  • 00858340006288 ()


  • X-ray system tube support, ceiling mounted

Del Medical/Universal - 00858340006264

An x-ray system component intended to be mounted to the floor, to support and facilitate position of the x-ray tube. The FMT18M does not allow for synchronized tracking and stitching.
Del Medical, Inc.
FMT18M
In Commercial Distribution

  • 00858340006264 ()


  • X-ray system tube support, floor standing

Legend Pro - 07290016586176

Legend Pro VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin.
POLLOGEN LTD
Legend Pro
In Commercial Distribution

  • 07290016586176 ()
20900330U

  • Radio-frequency skin surface treatment system

LightBeam - 00810323001918

50 Pieces of Lighted Large Circle Loop Curettte
EAR TECHNOLOGY CORPORATION
LB05-Refill
In Commercial Distribution



  • Endaural wax extraction curette
  • ENT illuminating foreign body extraction set

LightBeam - 00810323001888

50 pieces of Lighted Narrow Spoon Curette
EAR TECHNOLOGY CORPORATION
LB08-Refill
In Commercial Distribution

  • 00810323001888 ()


  • ENT illuminating foreign body extraction set
  • Endaural wax extraction curette

LightBeam - 00810323001871

50 pieces of Lighted Small Circle Loop Curette
EAR TECHNOLOGY CORPORATION
LB07-Refill
In Commercial Distribution

  • 00810323001871 ()


  • ENT illuminating foreign body extraction set
  • Endaural wax extraction curette

LightBeam - 00810323001864

50 Pieces of Lighted Large Spoon Curette
EAR TECHNOLOGY CORPORATION
LB06-Refill
In Commercial Distribution

  • 00810323001864 ()


  • Endaural wax extraction curette
  • ENT illuminating foreign body extraction set

LightBeam - 00810323001857

50 Pieces of Lighted Large Circle Loop Curettte
EAR TECHNOLOGY CORPORATION
LB05-Refill
In Commercial Distribution

  • 00810323001857 ()


  • Endaural wax extraction curette
  • ENT illuminating foreign body extraction set

LightBeam - 00810323001840

50 pieces of Lighted Small Tri-Loop Curette
EAR TECHNOLOGY CORPORATION
LB04-Refill
In Commercial Distribution

  • 00810323001840 ()


  • Endaural wax extraction curette
  • ENT illuminating foreign body extraction set
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