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

Show Filters

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
The Model 2504 Clinician Programmer Kit consists of a Model 2502 Clinician Programmer, a Model 2402 Mobile Charger, a Model 2403-300 Clinician Transmit Coil, a Model 1620 AC Recharger, and a Model 1600 Programmer Cable that are packaged together.
Reshape Lifesciences Inc.
2504
Not in Commercial Distribution

  • 00857334004361 ()
2504

  • Vagus nerve electrical stimulation system programmer
The Model 2502 Clinician Programmer (CP) is a non-sterile external component that consists of a commercially available laptop computer configured with customized software. The CP connects to the Mobile Charger with a custom Programmer Cable. The CP enables the clinician to enter and modify therapy parameters and therapy schedule in the Rechargeable Neuroregulator. The graphical user interface of the CP allows the clinician to monitor system performance and patient compliance. The CP also provides access to the Instructions for Use manuals.
Reshape Lifesciences Inc.
2502
Not in Commercial Distribution

  • 00857334004354 ()
2502

  • Vagus nerve electrical stimulation system programmer
The Model 2403-60 Transmit Coil is a non-sterile external component for use by the patient. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication.
Reshape Lifesciences Inc.
2403-60
Not in Commercial Distribution

  • 00857334004323 ()

  • Outer Diameter: 5 Inch
2403-60

  • Vagus nerve electrical stimulation system programmer
The Model 2403-300 Transmit Coil is a non-sterile external component that is placed within a standard sterile sleeve for use by a clinician in the operating room. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication.
Reshape Lifesciences Inc.
2403-300
Not in Commercial Distribution

  • 00857334004316 ()

  • Outer Diameter: 5 Inch
2403-300

  • Vagus nerve electrical stimulation system programmer
The Model 1600 Programmer Cable is a non-sterile external component that is used to provide connectivity between the Model 2502 Clinician Programmer and the Model 2402 Mobile Charger.
Reshape Lifesciences Inc.
1600
Not in Commercial Distribution

  • 00857334004194 ()

  • Length: 60 Inch
1600

  • Vagus nerve electrical stimulation system programmer
Handpiece
STRYKER CORPORATION
SSA-104
In Commercial Distribution

  • 00857326005659 ()


  • ENT shaver system handpiece
Shaver System
STRYKER CORPORATION
SS-100
In Commercial Distribution

  • 00857326005635 ()


  • ENT shaver system
Sinonasal Suction and Irrigation System
STRYKER CORPORATION
CC-100
In Commercial Distribution

  • 00857326005499 ()


  • Surgical/emergency suction cannula, non-illuminating, single-use
  • Nasal irrigation set, clinical
Spanish - Anasept Antimicrobial Skin and Wound cleanser filled in 8 oz. cone top, HDPE bottles with Trigger sprayer
ARGENTUM MEDICAL, LLC
4008TCS
In Commercial Distribution

  • 10857278000914 ()
  • 00857278000917 ()


  • Antimicrobial wound irrigation solution
Acute Burn Glove 2 Extra Large
ARGENTUM MEDICAL, LLC
ABG-01XXL
In Commercial Distribution

  • 00857278000757 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Acute Burn Glove X-Large
ARGENTUM MEDICAL, LLC
ABG-01XL
In Commercial Distribution

  • 00857278000740 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Acute Burn Glove Large
ARGENTUM MEDICAL, LLC
ABG-01L
In Commercial Distribution

  • 00857278000733 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Acute Burn Glove Medium
ARGENTUM MEDICAL, LLC
ABG-01M
In Commercial Distribution

  • 00857278000726 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Acute Burn Glove Small
ARGENTUM MEDICAL, LLC
ABG-01S
In Commercial Distribution

  • 00857278000719 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Acute Burn Glove X-Small
ARGENTUM MEDICAL, LLC
ABG-01XS
In Commercial Distribution

  • 00857278000702 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Burn Pad Dressing 8in x 16in
ARGENTUM MEDICAL, LLC
BPD-816
In Commercial Distribution

  • 10857278000693 ()
  • 00857278000696 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Burn Pad Dressing 4in x 8in
ARGENTUM MEDICAL, LLC
BPD-48
In Commercial Distribution

  • 10857278000686 ()
  • 00857278000689 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Burn Pad Dressing 4in x 5in
ARGENTUM MEDICAL, LLC
BPD-44
In Commercial Distribution

  • 10857278000679 ()
  • 00857278000672 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Digit Sleeve 1in x 12in
ARGENTUM MEDICAL, LLC
DS-112
In Commercial Distribution

  • 10857278000655 ()
  • 00857278000658 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Burn Wrap Dressing 6in x 108in
ARGENTUM MEDICAL, LLC
BWD-6108
In Commercial Distribution

  • 00857278000597 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Burn Wrap Dressing 4in x 66in
ARGENTUM MEDICAL, LLC
BWD-466
In Commercial Distribution

  • 00857278000580 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Burn Contact Dressing Chest - Medium 26in x 25in
ARGENTUM MEDICAL, LLC
BCD-CDM
In Commercial Distribution

  • 00857278000566 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Burn Contact Dressing Chest - Large 30in x 25.5in
ARGENTUM MEDICAL, LLC
BCD-CDL
In Commercial Distribution

  • 00857278000559 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Burn Contact Dressing 24in x 24in
ARGENTUM MEDICAL, LLC
BCD-2424
In Commercial Distribution

  • 00857278000542 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Burn Contact Dressing 16in x 16in
ARGENTUM MEDICAL, LLC
BCD-1616
In Commercial Distribution

  • 00857278000535 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Burn Contact Dressing 8in x 16in
ARGENTUM MEDICAL, LLC
BCD-816
In Commercial Distribution

  • 10857278000525 ()
  • 00857278000528 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Burn Contact Dressing 4in x 8in
ARGENTUM MEDICAL, LLC
BCD-48
In Commercial Distribution

  • 10857278000518 ()
  • 00857278000511 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Burn Contact Dressing 4in x 5in
ARGENTUM MEDICAL, LLC
BCD-44
In Commercial Distribution

  • 00857278000504 ()
  • 10857278000501 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Wound Pad Dressing 4in x 5in
ARGENTUM MEDICAL, LLC
WPD-44
In Commercial Distribution

  • 10857278000396 ()
  • 00857278000399 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Wound Pad Dressing 3in x 16in
ARGENTUM MEDICAL, LLC
WPD-316
In Commercial Distribution

  • 10857278000389 ()
  • 00857278000382 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Wound Pad Dressing 3in x 10in
ARGENTUM MEDICAL, LLC
WPD-310
In Commercial Distribution

  • 10857278000372 ()
  • 00857278000375 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Wound Pad Dressing 3in x 8in
ARGENTUM MEDICAL, LLC
WPD-38
In Commercial Distribution

  • 10857278000365 ()
  • 00857278000368 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Wound Pad Dressing 2in x 12in
ARGENTUM MEDICAL, LLC
WPD-212
In Commercial Distribution

  • 10857278000358 ()
  • 00857278000351 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Wound Pad Dressing 2in x 10in
ARGENTUM MEDICAL, LLC
WPD-210
In Commercial Distribution

  • 10857278000341 ()
  • 00857278000344 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Wound Pad Dressing 2in x 8in
ARGENTUM MEDICAL, LLC
WPD-28
In Commercial Distribution

  • 10857278000334 ()
  • 00857278000337 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Wound Pad Dressing 2in x 6in
ARGENTUM MEDICAL, LLC
WPD-26
In Commercial Distribution

  • 10857278000327 ()
  • 00857278000320 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Wound Pad Dressing 2in x 3in
ARGENTUM MEDICAL, LLC
WPD-23
In Commercial Distribution

  • 10857278000310 ()
  • 00857278000313 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Wound Pad Dressing 2in x 2in
ARGENTUM MEDICAL, LLC
WPD-22
In Commercial Distribution

  • 10857278000303 ()
  • 00857278000306 ()


  • Wound-nonadherent dressing, absorbent, antimicrobial
Wound Contact Dressing 4in x 66in
ARGENTUM MEDICAL, LLC
WCD-466
In Commercial Distribution

  • 00857278000054 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
Wound Contact Dressing 10in x 12in
ARGENTUM MEDICAL, LLC
WCD-1012
In Commercial Distribution

  • 10857278000044 ()
  • 00857278000047 ()


  • Wound-nonadherent dressing, permeable, antimicrobial
< 1 ... 92 93 94 95 96 ... 200 >