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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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No Description
TRICE MEDICAL, INC.
T600-013
In Commercial Distribution

  • 00857356008798 ()
  • 00857356008835 ()
T600-013

  • Hard/soft-tissue ultrasonic surgical system
No Description
TRICE MEDICAL, INC.
T600-020
In Commercial Distribution

  • 00857356008781 ()
  • 00857356008828 ()
T600-020

  • Hard/soft-tissue ultrasonic surgical system
No Description
TRICE MEDICAL, INC.
T600-025
In Commercial Distribution

  • 00857356008774 ()
  • 00857356008811 ()
T600-025

  • Hard/soft-tissue ultrasonic surgical system
No Description
TRICE MEDICAL, INC.
T600-030
In Commercial Distribution

  • 00857356008767 ()
  • 00857356008804 ()
T600-030

  • Hard/soft-tissue ultrasonic surgical system
DOA 12 in 1 Test ECO II Cup W/ AD, 25Pcs/Box; First Sign for Hemosure AMP/BARB/BUP/BZO/COC/mAMP/MDMA/MTD/OPI/OXY/PCP/THC/PH-SG-OX
HEMOSURE INC.
FSCECOII-9124 W/AD
In Commercial Distribution

  • 00857338006958 ()
  • 00817763020011 ()
FSCECOII-9124 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test ECO II Cup W/ AD, 25Pcs/Box; First Sign for Hemosure AMP/BUP/BZO/COC/mAMP/MDMA/MOR/MTD/OXY/THC/PH-SG-OX
HEMOSURE INC.
FSCECOII-47104 W/AD
In Commercial Distribution

  • 00857338006941 ()
  • 00817763020028 ()
FSCECOII-47104 W/AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/COC/mAMP/MTD/OPI/OXY
HEMOSURE INC.
FSCECOII-5764
In Commercial Distribution

  • 00857338006910 ()
  • 00857338006927 ()
FSCECOII-5764

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived AMP/COC/MTD/OPI/THC
HEMOSURE INC.
FSCECOII-4854
In Commercial Distribution

  • 00857338006897 ()
  • 00857338006903 ()
FSCECOII-4854

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 5 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/COC/MTD/OPI/THC
HEMOSURE INC.
FSCW4854
In Commercial Distribution

  • 00857338006880 ()
  • 00841824102781 ()
FSCW4854

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 12 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BARB/BUP/BZO/COC/mAMP/MOR/MTD/OPI/OXY/PCP/THC
HEMOSURE INC.
FSCECOII-19124
In Commercial Distribution

  • 00857338006835 ()
  • 00857338006842 ()
FSCECOII-19124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test ECO II Cup, 25Pcs/Box; First Sign for Hemosure AMP/BUP/BZO/COC/mAMP/MOR/MTD/OPI/OXY/THC
HEMOSURE INC.
FSCECOII-36104
In Commercial Distribution

  • 00857338006811 ()
  • 00857338006828 ()
FSCECOII-36104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 10 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/BUP/BZO/COC/mAMP/MOR/MTD/OPI/OXY/THC
HEMOSURE INC.
FSCW36104
In Commercial Distribution

  • 00857338006774 ()
  • 00841824102019 ()
FSCW36104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 12 in 1 Test Dip card, 25Pcs/Box; First Sign for Hemosure AMP/BARB/BUP/BZO/COC/mAMP/MOR/MTD/OPI/OXY/PCP/THC
HEMOSURE INC.
FSCW19124
In Commercial Distribution

  • 00857338006767 ()
  • 00841824102002 ()
FSCW19124

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
DOA 6 in 1 Test Dipcard, 25Pcs/Box; First Sign for Hemosure, AMP/COC/MTD/OPI/OXY/THC
HEMOSURE INC.
FSCW5964
In Commercial Distribution

  • 00857338006286 ()
  • 00857338006873 ()
FSCW5964

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Hemosure hCG Controls Set 2mL. One positive and one negative.
HEMOSURE INC.
F2-TC01
Not in Commercial Distribution

  • 00857338006262 ()
F2-TC01

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
Individual Prepacked Mailer with One Tube in Each Mailer; Packed in a Plastic Bag
HEMOSURE INC.
Prepack-CM25
In Commercial Distribution

  • 00857338006101 ()
  • 00857338006170 ()
Prepack-CM25

  • Faecal occult blood IVD, kit, rapid ICT, clinical
Hemosure iFOB Prepacked iFOB Test 20 Cassettes and 20 Mailers Box Kit with One Buffer Tube in Each Mailer
HEMOSURE INC.
PRE-PACK iFOB20
In Commercial Distribution

  • 00857338006040 ()
  • 00857338006002 ()
PRE-PACK iFOB20

  • Faecal occult blood IVD, kit, rapid ICT, clinical
Rejoyn (also known as CT-152) is a digital therapeutic smartphone application (app) for the treatment of Major Depressive Disorder (MDD) symptoms. Rejoyn is a prescription smartphone app-based digital therapeutic administered to a user via the user’s smartphone device (running Apple iPhone operating system [iOS®] or Android™ operating system [OS]), which delivers a proprietary interactive cognitive emotional and behavioral therapeutic intervention. The core components of Rejoyn are the Emotional Faces Memory Task (EFMT) exercises, brief cognitive behavioral therapy (CBT)-based lessons to learn and apply key therapeutic skills, and short message service (SMS) text messaging to reinforce CBT-based lesson content and to encourage engagement with the app. It is intended for the treatment of MDD symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older. It is intended to reduce MDD symptoms. Rejoyn is designed for use as an adjunct to clinician-managed outpatient care over a period of 6 weeks for the treatment of MDD symptoms, followed by a 4-week extension period where CBT-based lesson content will be accessible but no new therapeutic content or EFMT exercises will be available. Rejoyn is not intended to be used as a stand-alone therapy or as a substitution for the patient’s clinician prescribed medications.
Otsuka Pharmaceutical Development & Commercialization, Inc.
CT-152
In Commercial Distribution

  • 00857335005121 ()
  • 57335-0005-12 ()
57335000512

  • Mental health/function therapeutic software, screen-viewed
2 component patch RW2
Otsuka America Pharmaceutical Inc
RW2
In Commercial Distribution

  • 00857335005091 ()


  • Wearable multiple physiological parameter recorder, reusable
DW5 replacement patch
Otsuka America Pharmaceutical Inc
DW5
Not in Commercial Distribution

  • 00857335005053 ()


  • Wearable multiple physiological parameter recorder, reusable
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