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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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aScope™ 4 Cysto - 05707480140558

aScope 4 Cysto - Reverse Deflection
Ambu A/S
600001000
In Commercial Distribution

  • 05707480140565 ()
  • 05707480140558 ()
  • 05707480140572 ()

  • Length: 390 Millimeter
  • Outer Diameter: 6 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
600001000

  • Flexible video cystoscope, single-use

Ambu® aScope™ 5 Cysto HD - 05707480164493

Flexible Cystoscope, Standard Deflection
Ambu A/S
603101000
In Commercial Distribution

  • 05707480164516 ()
  • 05707480164509 ()
  • 05707480164493 ()

  • Lumen/Inner Diameter: 2.2 Millimeter
  • Outer Diameter: 6 Millimeter
603101000

  • Flexible video cystoscope, single-use

Ambu® aScope™ 5 Cysto HD - 05707480164462

Flexible Cystoscope, Reverse Deflection
Ambu A/S
602101000
In Commercial Distribution

  • 05707480164486 ()
  • 05707480164479 ()
  • 05707480164462 ()

  • Outer Diameter: 6 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
602101000

  • Flexible video cystoscope, single-use

Ambu® aScope™ 5 Uretero - 05707480161584

Flexible Ureteroscope, Reverse Deflection
Ambu A/S
605101000
In Commercial Distribution

  • 05707480161591 ()
  • 05707480161584 ()
  • 05707480161607 ()

  • Lumen/Inner Diameter: 1.2 Millimeter
  • Outer Diameter: 3 Millimeter
  • Length: 780 Millimeter
605101000

  • Flexible video ureterorenoscope, single-use

Ambu® aScope™ 5 Uretero - 05707480161553

Flexible Ureteroscope, Standard Deflection
Ambu A/S
604101000
In Commercial Distribution

  • 05707480161560 ()
  • 05707480161553 ()
  • 05707480161577 ()

  • Length: 780 Millimeter
  • Lumen/Inner Diameter: 1.2 Millimeter
  • Outer Diameter: 3 Millimeter
604101000

  • Flexible video ureterorenoscope, single-use

Ambu® SureSight® Connect - 05707480159383

Reusable Video Laryngoscope Adapter
Ambu A/S
390511000
In Commercial Distribution

  • 05707480159390 ()
  • 05707480159383 ()
390511000

  • Electrical-only medical device connection cable, reusable

Ambu® SureSight® Blade - 05707480159352

Video Laryngoscope Blade
Ambu A/S
390341000
In Commercial Distribution

  • 05707480159369 ()
  • 05707480159352 ()
  • 05707480159376 ()

  • MAC #4
390341000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159321

Video Laryngoscope Blade
Ambu A/S
390331000
In Commercial Distribution

  • 05707480159338 ()
  • 05707480159321 ()
  • 05707480159345 ()

  • MAC #3
390331000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159291

Video Laryngoscope Blade
Ambu A/S
390241000
In Commercial Distribution

  • 05707480159314 ()
  • 05707480159307 ()
  • 05707480159291 ()

  • HYPER #4
390241000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159260

Video Laryngoscope Blade
Ambu A/S
390531000
In Commercial Distribution

  • 05707480159277 ()
  • 05707480159260 ()
  • 05707480159284 ()

  • HYPER #3C
390531000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159239

Video Laryngoscope Blade
Ambu A/S
390231000
In Commercial Distribution

  • 05707480159246 ()
  • 05707480159239 ()
  • 05707480159253 ()

  • HYPER #3
390231000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159208

Video Laryngoscope Blade
Ambu A/S
390521000
In Commercial Distribution

  • 05707480159222 ()
  • 05707480159215 ()
  • 05707480159208 ()

  • HYPER #2C
390521000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159178

Video Laryngoscope Blade
Ambu A/S
390221000
In Commercial Distribution

  • 05707480159192 ()
  • 05707480159185 ()
  • 05707480159178 ()

  • HYPER #2
390221000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159147

Video Laryngoscope Blade
Ambu A/S
390211000
In Commercial Distribution

  • 05707480159154 ()
  • 05707480159147 ()
  • 05707480159161 ()

  • HYPER #1
390211000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159116

Video Laryngoscope Blade
Ambu A/S
390111000
In Commercial Distribution

  • 05707480159123 ()
  • 05707480159116 ()
  • 05707480159130 ()

  • MILLER #1
390111000

  • Laryngoscope blade, single-use

Ambu® SureSight® Blade - 05707480159086

Video Laryngoscope Blade
Ambu A/S
390101000
In Commercial Distribution

  • 05707480159109 ()
  • 05707480159093 ()
  • 05707480159086 ()

  • MILLER #0
390101000

  • Laryngoscope blade, single-use

Avery Breathing Pacemaker System - 00850252006066

Digital Transmitter for the Avery Breathing Pacemaker System
Avery Biomedical Devices Inc
NeurostimulatorTransmitter Digital
In Commercial Distribution

  • 00850252006066 ()
Spirit

  • Extramuscular diaphragm/phrenic nerve electrical stimulation system

EndoSound® Transducer Extension Connector (TEC) - 00850050934011

The EndoSound Transducer Extension Connector (TEC) includes the electrical connectors and cable between the EVSScanner and the UTM.
Endosound, Inc.
5002
In Commercial Distribution

  • 00850050934011 ()
5002

  • General-purpose ultrasound imaging system

EndoSound® Ultrasound Transducer Module (UTM) - 00850050934165

EndoSound Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy.
Endosound, Inc.
5016
In Commercial Distribution

  • 00850050934165 ()
5016

  • Flexible endoscopic ultrasound imaging transducer

EndoSound® Vision System (EVS) Software - 00850050934127

The EndoSound Vision System (EVS) Software is the Microsoft Windows-based software run on a PC that processes the ultrasound data received from the EVSScanner module and displays the ultrasound image on the PC's monitor.
Endosound, Inc.
5011
In Commercial Distribution

  • 00850050934127 ()
5011

  • General-purpose ultrasound imaging system

EndoSound® Air Leak Tester - 00850050934110

The EndoSound Air Leak Tester is used with a UTM and pressure test cap to test the integrity of the UTM cable.
Endosound, Inc.
5030
In Commercial Distribution

  • 00850050934110 ()
5030

  • Invasive medical device leak tester, mechanical

EndoSound® Ultrasound Disposable Kit (UDK-T) 5008 - 00850050934103

EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.3mm Wall Thickness: 0.7mm
Endosound, Inc.
5008
In Commercial Distribution

  • 00850050934103 ()
  • 00850050934066 ()

  • Lumen/Inner Diameter: 9.3 Millimeter
  • .7mm wall thickness
5007

  • General-purpose ultrasound imaging system

EndoSound® Ultrasound Disposable Kit (UDK-T) 5010 - 00850050934097

EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.5mm Wall Thickness: 1.25mm
Endosound, Inc.
5010
In Commercial Distribution

  • 00850050934097 ()
  • 00850050934059 ()

  • Lumen/Inner Diameter: 9.5 Millimeter
  • 1.25mm wall thickness
5009

  • General-purpose ultrasound imaging system

EndoSound® Ultrasound Disposable Kit (UDK-T) 5006 - 00850050934080

EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 9mm Wall Thickness: 1mm
Endosound, Inc.
5006
In Commercial Distribution

  • 00850050934080 ()
  • 00850050934073 ()

  • Lumen/Inner Diameter: 9 Millimeter
  • 1mm wall thickness
5005

  • General-purpose ultrasound imaging system

EndoSound® Ultrasound Disposable Kit (UDK-T) 5004 - 00850050934042

EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 10.5mm Wall Thickness: 0.5mm
Endosound, Inc.
5004
In Commercial Distribution

  • 00850050934042 ()
  • 00850050934004 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • .5mm wall thickness
5003

  • General-purpose ultrasound imaging system

EndoSound® Ultrasound Transducer Module (UTM) - 00850050934035

EndoSound Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy.
Endosound, Inc.
5001
In Commercial Distribution

  • 00850050934035 ()
5001

  • Flexible endoscopic ultrasound imaging transducer

EndoSound® EVSScanner - 00850050934028

The EndoSound Vision System (EVS) Scanner is a small, portable, self-contained module that contains the electronics that perform ultrasound scanning and receiving functions (beamforming).
Endosound, Inc.
5000
In Commercial Distribution

  • 00850050934028 ()
5000

  • General-purpose ultrasound imaging system

Care Continuum Chair - 00850043655008

The TPM Research model CCC-1000 Care Continuum Chair is a manual operator-propelled chair that is designed for transport and use of seated occupants with their associated medical equipment (including oxygen bottle or IV fluid bags). The product is equipped with an electronic positioning system that assists with occupant entry and exit.
Tpm Research, Inc.
CCC-1000
In Commercial Distribution

  • 00850043655008 ()


  • Stand-assistive attendant-only-propelled wheelchair

Sleep Profiler PSG2 - 00850063034258

Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Swiss
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(SWISS)
In Commercial Distribution

  • 00850063034258 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system

Sleep Profiler PSG2 - 00850063034241

Sleep Profiler PSG2 LE Device Kit - Piezo (PVDF) Italian
ADVANCED BRAIN MONITORING, INC.
SP29-1006.LE(ITA)
In Commercial Distribution

  • 00850063034241 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
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