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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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Pelvic Floor Execiser System, Extended Vaginal Exerciser, For use with Liberty Stimulator PFS-200 only
UTAH MEDICAL PRODUCTS, INC.
Vaginal Exerciser with Handle
In Commercial Distribution

  • H671PFS0420 ()
PFS-042

  • Perineal orifice incontinence-control electrical stimulation system probe, reusable
Disposable Electrosurgical Electrode with ZapGuard, 0.16" (4mm) Blade Length, 6" (15cm) Bendable Shaft Length, 0.2mm Wire Diameter
UTAH MEDICAL PRODUCTS, INC.
Epitome .2 with ZapGuard
In Commercial Distribution

  • H671CBE2702 ()
  • H671CBE2701 ()
  • H671CBE2700 ()

  • Wire Diameter - 0.2 mm
  • Shaft Length - 6" (15cm)
  • Blade Length - 0.16" (4mm)
CBE-270

  • Open-surgery electrosurgical electrode, monopolar, single-use
Disposable Electrosurgical Electrode with ZapGuard, 0.16" (4mm) Blade Length, 4" (10cm) Bendable Shaft Length, 0.2mm Wire Diameter
UTAH MEDICAL PRODUCTS, INC.
Epitome .2 with ZapGuard
In Commercial Distribution

  • H671CBE2602 ()
  • H671CBE2601 ()
  • H671CBE2600 ()

  • Wire Diameter - 0.2 mm
  • Shaft Length - 4" (10cm)
  • Blade Length - 0.16" (4mm)
CBE-260

  • Open-surgery electrosurgical electrode, monopolar, single-use
Disposable Electrosurgical Electrode with ZapGuard, 0.16" (4mm) Blade Length, 2" (5cm) Bendable Shaft Length, 0.2mm Wire Diameter
UTAH MEDICAL PRODUCTS, INC.
Epitome .2 with ZapGuard
In Commercial Distribution

  • H671CBE2202 ()
  • H671CBE2201 ()
  • H671CBE2200 ()

  • Wire Diameter - 0.2 mm
  • Shaft Length - 2" (5cm)
  • Blade Length - 0.16" (4mm)
CBE-220

  • Open-surgery electrosurgical electrode, monopolar, single-use
BULK PACK, 5 LITER COLLECTION BAG W/ UNIVERSAL CONNECTOR
UTAH MEDICAL PRODUCTS, INC.
5 Liter with Connector
In Commercial Distribution

  • H671024511 ()
  • H671024510 ()

  • Total Volume: 5 Liter
02451

  • Gasometer
BAG, 5 LITER W/ BAG KEEPER
UTAH MEDICAL PRODUCTS, INC.
5 Liter with Keeper
In Commercial Distribution

  • H671024011 ()
  • H671024010 ()

  • Total Volume: 5 Liter
02401

  • Gasometer
BAG, 10 LITER W/ BAG KEEPER
UTAH MEDICAL PRODUCTS, INC.
10 Liter with Keeper
In Commercial Distribution

  • H671024001 ()
  • H671024000 ()

  • Total Volume: 10 Liter
02400

  • Gasometer
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage with strut
In Commercial Distribution

  • 04047844002032 ()

  • 6x13x14mm
N061314

  • Polymeric spinal interbody fusion cage
The basic shape of the NUBIC and RABEA devices is a rectangular frame. The upper and lower aspects of the implant are open with surface spikes which assist in the positive anchorage and seating between the superior and inferior vertebral bodies. The device is available in a variety of sizes enabling the surgeon to choose the size best suited to the individual pathology and anantomical condition. A connecting screw is available which permits attachment of the NUBIC (without strut) to the SIGNUS TOSCA II anterior cervical plate if the surgeon so chooses.
SIGNUS Medizintechnik GmbH
Cervical cage with strut
In Commercial Distribution

  • 04047844002018 ()

  • 4x13x14mm
N041314

  • Polymeric spinal interbody fusion cage
diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
eResearchTechnology GmbH
MasterScope WSSU with ECG
In Commercial Distribution

  • 04057155000641 ()


  • Diagnostic spirometer, professional
  • Electrocardiograph, professional, multichannel
diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
eResearchTechnology GmbH
MasterScope CT with ECG
In Commercial Distribution

  • 04057155000627 ()


  • Diagnostic spirometer, professional
  • Electrocardiograph, professional, multichannel
diagnostic spirometer for measurement and data collection of lung function parameters with option ECG
eResearchTechnology GmbH
MasterScope CT with ECG
In Commercial Distribution

  • 04057155000030 ()


  • Diagnostic spirometer, professional
  • Electrocardiograph, professional, multichannel
Revolution Apex Select with Plus Edition - Designated System Medical Device
Hangwei GE Medical Systems Co., Ltd.
Select with Plus Edition
In Commercial Distribution

  • 00195278788665 ()
B7919YO

  • Full-body CT system
AISYS CS2 WITH ET CONTROL
DATEX-OHMEDA INC
CS2 WITH ET CONTROL
In Commercial Distribution

  • 00195278588128 ()


  • Anaesthesia workstation, general-purpose
Revolution CT ES with Apex edition - Designated System Medical Device
GE MEDICAL SYSTEMS, INC.
ES with Apex edition
In Commercial Distribution

  • 00195278471277 ()
5826588

  • Full-body CT system
No Description
Heine Optotechnik GmbH & Co. KG
2,5 V WITH SCALE
In Commercial Distribution

  • 04053755158812 ()
D-008.78.108

  • Dermatoscope, optical
No Description
Heine Optotechnik GmbH & Co. KG
2,5 V WITH SCALE
In Commercial Distribution

  • 04053755124909 ()
D-001.78.108

  • Dermatoscope, optical
All Soft Ureteral Stent - 7F, 26cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 26cm with Suture
In Commercial Distribution

  • 10812261015276 ()
  • 00812261015279 ()
SOT 7/26-S

  • Polymeric ureteral stent
All Soft Ureteral Stent - 6F, 26cm with Suture
ALLWIN MEDICAL DEVICES, INC.
6F, 26cm with Suture
In Commercial Distribution

  • 10812261013753 ()
  • 00812261013756 ()
SOT 6/26-S

  • Polymeric ureteral stent
7F, 22cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 22cm with Suture
In Commercial Distribution

  • 10812261013210 ()
  • 00812261013213 ()
SOT 7/22-S

  • Polymeric ureteral stent
7F, 24cm with Suture
ALLWIN MEDICAL DEVICES, INC.
7F, 24cm with Suture
In Commercial Distribution

  • 10812261010691 ()
  • 00812261010694 ()
SOT 7/24-S

  • Polymeric ureteral stent
Stopper Screw for use with the Piccolo Composite Proximal Femur Nailing System.
CARBOFIX ORTHOPEDICS LTD
Stopper Screw With Pin
In Commercial Distribution

  • 07290117350683 ()
PPF910550

  • Orthopaedic implant aiming arm
No Description
LUMENIS LTD.
Kit with prolonged arm
In Commercial Distribution

  • 07290109142210 ()


  • General/multiple surgical solid-state/carbon dioxide laser system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516311790 ()
31179

  • Electronystagmograph
  • Dynamic visual acuity testing system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516227090 ()
22709

  • Electronystagmograph
  • Dynamic visual acuity testing system
The videonystagmography performed by a camera and infra red light measures and records the eye movement, which is analyzed by the software. NYSSTAR II is the essential tool to study the various functions of balance, namely the oculomotricity (ocular saccades, pursuit, optokinetic nystagmus) and the study of the vestibular system (spontaneous and positional nystagmi, rotary tests, caloric tests. NYSSTAR II is a nystagmography system and is able to record simultaneously both eyes movements, as well horizontal, as vertical. The calibration carried out by camera is stable and should only be made once at the beginning of the examination. The recording by camera removes all artefacts due to the changes of polarity between the electrodes and the skin like with the interferences of electric and electrophysiological origin. NYSSTAR IU is also equipped with gyroscope to record movements of the patient's head. Combination of movements of the eye and of the head allow to run specific oculomotor tests.
Instrumentation Difra SA
NysStar II with VOR
In Commercial Distribution

  • B516222210 ()
22221

  • Electronystagmograph
  • Dynamic visual acuity testing system
Siemens UNITY 3 WITH INSERTS
Ws Audiology Usa, Inc.
UNITY 3 WITH INSERTS
Not in Commercial Distribution

  • 57117810000743 ()
10824331

  • Audiometric/hearing aid tester
Organic Cotton Tampon, Menstrual, Unscented with Applicator Super 16 single use tampons per pack
BODYWISE (UK) LIMITED
Tampons with Applicator Super
In Commercial Distribution

  • 05019493090028 ()
  • 00782126009005 ()
  • 00782126009001 ()


  • Menstrual tampon, unscented
Organic Cotton Tampon, Menstrual, Unscented with Applicator Regular 16 single use tampons per pack
BODYWISE (UK) LIMITED
Tampons with Applicator Regular
In Commercial Distribution

  • 05019493080029 ()
  • 00782126008008 ()
  • 00782126008001 ()


  • Menstrual tampon, unscented
No Description
Tianck Medical Co., Ltd.
25cm with three-way stopcock
In Commercial Distribution

  • 06971162810728 ()
044004

  • Invasive blood pressure monitoring tubing set
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