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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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Cortera - 00810076568041

Screw, Poly, CC Cann, 5.5x25
Xtant Medical Holdings, Inc.
150103-55025
In Commercial Distribution

  • 00810076568041 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076568034

Screw, Poly, CC Cann, 5.0x120
Surgalign Spine Technologies, Inc.
150103-50120
In Commercial Distribution

  • 00810076568034 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076568027

Screw, Poly, CC Cann, 5.0x115
Surgalign Spine Technologies, Inc.
150103-50115
In Commercial Distribution

  • 00810076568027 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076568010

Screw, Poly, CC Cann, 5.0x110
Surgalign Spine Technologies, Inc.
150103-50110
In Commercial Distribution

  • 00810076568010 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076568003

Screw, Poly, CC Cann, 5.0x105
Surgalign Spine Technologies, Inc.
150103-50105
In Commercial Distribution

  • 00810076568003 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567990

Screw, Poly, CC Cann, 5.0x100
Surgalign Spine Technologies, Inc.
150103-50100
In Commercial Distribution

  • 00810076567990 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567983

Screw, Poly, CC Cann, 5.0x95
Surgalign Spine Technologies, Inc.
150103-50095
In Commercial Distribution

  • 00810076567983 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567976

Screw, Poly, CC Cann, 5.0x90
Surgalign Spine Technologies, Inc.
150103-50090
In Commercial Distribution

  • 00810076567976 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567969

Screw, Poly, CC Cann, 5.0x85
Surgalign Spine Technologies, Inc.
150103-50085
In Commercial Distribution

  • 00810076567969 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567952

Screw, Poly, CC Cann, 5.0x80
Surgalign Spine Technologies, Inc.
150103-50080
In Commercial Distribution

  • 00810076567952 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567945

Screw, Poly, CC Cann, 5.0x75
Surgalign Spine Technologies, Inc.
150103-50075
In Commercial Distribution

  • 00810076567945 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567938

Screw, Poly, CC Cann, 5.0x70
Surgalign Spine Technologies, Inc.
150103-50070
In Commercial Distribution

  • 00810076567938 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567921

Screw, Poly, CC Cann, 5.0x65
Surgalign Spine Technologies, Inc.
150103-50065
In Commercial Distribution

  • 00810076567921 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567914

Screw, Poly, CC Cann, 5.0x60
Xtant Medical Holdings, Inc.
150103-50060
In Commercial Distribution

  • 00810076567914 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567907

Screw, Poly, CC Cann, 5.0x55
Xtant Medical Holdings, Inc.
150103-50055
In Commercial Distribution

  • 00810076567907 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567891

Screw, Poly, CC Cann, 5.0x50
Xtant Medical Holdings, Inc.
150103-50050
In Commercial Distribution

  • 00810076567891 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567884

Screw, Poly, CC Cann, 5.0x45
Xtant Medical Holdings, Inc.
150103-50045
In Commercial Distribution

  • 00810076567884 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567877

Screw, Poly, CC Cann, 5.0x40
Xtant Medical Holdings, Inc.
150103-50040
In Commercial Distribution

  • 00810076567877 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567860

Screw, Poly, CC Cann, 5.0x35
Xtant Medical Holdings, Inc.
150103-50035
In Commercial Distribution

  • 00810076567860 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567853

Screw, Poly, CC Cann, 5.0x30
Xtant Medical Holdings, Inc.
150103-50030
In Commercial Distribution

  • 00810076567853 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567846

Screw, Poly, CC Cann, 5.0x25
Xtant Medical Holdings, Inc.
150103-50025
In Commercial Distribution

  • 00810076567846 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567839

Screw, Poly, CC Cann, 4.5x120
Surgalign Spine Technologies, Inc.
150103-45120
In Commercial Distribution

  • 00810076567839 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567822

Screw, Poly, CC Cann, 4.5x115
Surgalign Spine Technologies, Inc.
150103-45115
In Commercial Distribution

  • 00810076567822 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567815

Screw, Poly, CC Cann, 4.5x110
Surgalign Spine Technologies, Inc.
150103-45110
In Commercial Distribution

  • 00810076567815 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567808

Screw, Poly, CC Cann, 4.5x105
Surgalign Spine Technologies, Inc.
150103-45105
In Commercial Distribution

  • 00810076567808 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567792

Screw, Poly, CC Cann, 4.5x100
Surgalign Spine Technologies, Inc.
150103-45100
In Commercial Distribution

  • 00810076567792 ()


  • Bone-screw internal spinal fixation system, non-sterile

Cortera - 00810076567785

Screw, Poly, CC Cann, 4.5x95
Surgalign Spine Technologies, Inc.
150103-45095
In Commercial Distribution

  • 00810076567785 ()


  • Bone-screw internal spinal fixation system, non-sterile

VIEW PLATING SYSTEM - REDUCE FRACTURE PLATING SYSTEM - 18053800893517

RIVAL TI CC PLATE LARGE
ORTHOFIX SRL
1
Not in Commercial Distribution

  • 18053800893517 ()
102-G-01030

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

ICU Medical - 00887709042759

10 cc Contamination Sheath Syringe
ICU MEDICAL, INC.
42052-01
In Commercial Distribution

  • 10887709042756 ()
  • 00887709042759 ()
42052-01

  • Angiography kit

Flo - 05060630101497

MEGA-AMZ-TAMP-1 - FLO Organic Cotton App Tampons Regular Pack (80 Tampons)
HERE WE FLO LTD
MEGA-AMZ-TAMP-1
In Commercial Distribution

  • 05060630101497 ()


  • Menstrual tampon, unscented

Oticon - 05707131268563

STRPR 1.2 APP, LINKED BL STREAMER PRO 1.2 NO LOGO
Oticon A/S
139346
In Commercial Distribution

  • 05707131268563 ()


  • Hearing aid neck induction loop, wireless input

Oticon - 05707131268549

STRPR 1.2 APP, LINKED WH STREAMER PRO 1.2 NO LOGO
Oticon A/S
139342
In Commercial Distribution

  • 05707131268549 ()


  • Hearing aid neck induction loop, wireless input

Med Aire - 00822383536323

Med Aire Assure 5" Air + 3" Foam APP and LAL
Drive Devilbiss Healthcare
14530
In Commercial Distribution

  • 00822383536323 ()


  • Alternating-pressure bed mattress overlay, reusable
  • Alternating-pressure inflator
  • Alternating-pressure bed mattress overlay system

Marina Medical - 00840306836374

Wireless Endoscopic Camera System with Wifi, 1080p, Endovision App, White
MARINA MEDICAL INSTRUMENTS, INC.
350-525
In Commercial Distribution

  • 00840306836374 ()
350-525

  • Endoscope video camera

Meridian Medical - 00815067043521

Meridian Medical APP System - adjustable pump and single layer pad
COMPASS HEALTH BRANDS CORP.
MER-APP2
In Commercial Distribution

  • 00815067043521 ()


  • Alternating-pressure bed mattress overlay system

FIBRIJET - 00815634020085

SPRAY SET ENDOSCOPIC APP. 5MM, 40 CM, 1:1 RATIO
Micromedics, Inc.
SA-3655
In Commercial Distribution

  • 00815634020085 ()
  • 10815634020082 ()
  • 20815634020089 ()


  • Open-surgery adhesive/sealant applicator, dual-channel

Cora - 00810042480568

Cora Tampons, DTC, App. Light 5/Reg. 6/Super 5
Cora
02Tampons-105
In Commercial Distribution

  • 00850373007041 ()
  • 00810042480568 ()


  • Menstrual tampon, unscented

myDigitalKnee® - 09413000126273

myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App Android
In Commercial Distribution

  • 09413000126273 ()


  • Electronic goniometer/kinesiology sensor

myDigitalKnee® - 09413000126259

myDigitalKnee mobile app is used with a Digital Knee sensor attached to a brace or orthosis and worn by a patient to collect motion data and assist with management of their condition.
OPUM TECHNOLOGIES SERVICES LIMITED
Mobile App iOS
In Commercial Distribution

  • 09413000126259 ()


  • Electronic goniometer/kinesiology sensor

EBM - 04719878879965

No Description
EBM TECHNOLOGIES INCORPORATED
MobiPACS™ App
In Commercial Distribution

  • 04719878879965 ()


  • Radiological PACS software

Persona Medical - 00851362008148

Windows Desktop based APP used to control Evok 1600 OTE/BTE device. A USB Bluetooth dongle will be used as an interface between the software and device. Also, remote support will be available through the APP to user to help with programming changes to improve their hearing needs.
Persona Medical
Persona APP Desktop
In Commercial Distribution

  • 00851362008148 ()


  • Air-conduction hearing aid, behind-the-ear

myBETAapp - 05713495000060

No Description
Phillips-Medisize A/S
Android (Mobile App)
Not in Commercial Distribution

  • 05713495000060 ()
84601063

  • Medication reminder application software

myBETAapp - 05713495000053

No Description
Phillips-Medisize A/S
iOS (Mobile App)
Not in Commercial Distribution

  • 05713495000053 ()
84601063

  • Medication reminder application software

EpiMonitor - 00853858006386

No Description
EMPATICA SRL
EpiMonitor App Android
In Commercial Distribution

  • 00853858006386 ()


  • Home seizure monitoring system

EpiMonitor - 00853858006379

No Description
EMPATICA SRL
EpiMonitor App iOS
In Commercial Distribution

  • 00853858006379 ()


  • Home seizure monitoring system

Empatica Health Monitoring Platform - 00853858006249

No Description
EMPATICA SRL
Care App iOS
In Commercial Distribution

  • 00853858006249 ()


  • Multiple vital physiological parameter monitoring system, home-use

actiTENS - B786SBM2AA2100

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS iOS app
In Commercial Distribution

  • B786SBM2AA2100 ()
SBM2AA210

  • Analgesic transcutaneous electrical nerve stimulation system

actiTENS - B786SBM2AA1100

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people. The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient. The impulse generator is delivered with a separate cradle which allows safely recharging its non- removable battery. The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric. The actiTENS is controlled via a downloadable mobile app which allows the comfortable and simple selection of the adequate stimulation program. The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals. It is available for prescription only.
SUBLIMED
actiTENS Android app
In Commercial Distribution

  • B786SBM2AA1100 ()
SBM2AA110

  • Analgesic transcutaneous electrical nerve stimulation system

Dover - 10192253028829

IRRIGATION 1200 CC TRAY, 60 CC PISTON SYRINGE, STERILE SALINE, TIP PROTECTOR, ALCOHOL, LIDDED
Cardinal Health 200, LLC
68820
In Commercial Distribution

  • 50192253028827 ()
  • 10192253028829 ()

  • Total Volume: 60 Milliliter
68820-

  • Irrigation syringe

ARROW - 00801902026477

Spring-Wire Guide for use with Standard 30 cc and 40 cc Intra-Aortic Balloon Catheters
TELEFLEX INCORPORATED
IPN000220
In Commercial Distribution

  • 30801902026478 ()
  • 00801902026477 ()

  • Length: 175 Centimeter
  • Outer Diameter: 0.025 Inch
IAA-03270

  • Intra-aortic balloon catheter
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