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Piezosurgery FLEX is an ultrasonic surgical system consisting of handpieces and associated tips for cutting bone, osteotomy, osteoplasty and drilling in variety of surgical procedures, including but not limited to otolaryngological, oral/maxillofacial, hand, foot, neurosurgical, spine, and plastic/reconstructive
surgery.
It may also be used with endloscopic visual assistance to perform the above listed procedures.
MECTRON SPA
PIEZOSURGERY FLEX
In Commercial Distribution
- E322040000950 ()
04000095
- Dental ultrasonic surgical system
The COMPACT-PIEZO P2K LED is an ultrasonic scaler device intended for use, with the appropriate associated insert tips, in the
following dental applications:
• Scaling: Procedures for removal of supragingival/subgingival and interdental calculus/plaque deposits;
• Periodontology: Periodontal therapy and debridement for periodontal diseases, including periodontal pocket irrigation
and cleaning;
• Endodontics: Treatments for root canal reaming irrigation, revision, filling, gutta-percha condensation and retrograde
preparation;
• Restorative and Prosthetics: Restorative procedures including cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations, inlay/onlay condensation and implants/restorations cleaning.
MECTRON SPA
COMPACT-PIEZO P2K LED
In Commercial Distribution
- E322040000910 ()
04000091
- Ultrasonic dental scaling/debridement system
Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: ·
1) Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
2) Scaling applications, including:
• Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
• Perlodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket Irrigation and cleaning;
• Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation;
• Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
MECTRON SPA
PIEZOSURGERY TOUCH
In Commercial Distribution
- E322040000860 ()
04000086
- Ultrasonic dental scaling/debridement system
- Dental ultrasonic surgical system
The Compact Piezo P2K device is an ultrasonic scaler intended for use, with the appropriate associated insert tips, in the following dental applications:
Scaling: All general procedures for removal of supragingival and interdental calculus/plaque deposits.
Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning.
Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and Retrograde preparation.
Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
MECTRON SPA
COMPACT-PIEZO P2K
In Commercial Distribution
- E322040000790 ()
04000079
- Ultrasonic dental scaling/debridement system
No Description
BLUO ELECTRONICS SRL
9319001700
In Commercial Distribution
- E3159319001700 ()
- Stationary intraoral dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468600008
In Commercial Distribution
- E3158468600008 ()
- Stationary panoramic dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468600007
In Commercial Distribution
- E3158468600007 ()
- Stationary panoramic dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468600002
In Commercial Distribution
- E3158468600002 ()
- Stationary panoramic/tomographic dental x-ray system, digital
No Description
BLUO ELECTRONICS SRL
8468600000
In Commercial Distribution
- E3158468600000 ()
- Stationary panoramic/tomographic dental x-ray system, digital
The Powered Breast Pump is intended to express and collect the breast milk of a nursing woman for the purpose of feeding the collected milk to a baby.
LANSINOH LABORATORIES SAGLIK GERECLERI TASARIM SANAYI TICARET LTD STI
Smartpump 3.0 Double Electric Breast Pump
In Commercial Distribution
- 60044677533517 ()
- 00044677533515 ()
53351
- Breast pump, electric
Ultrasonic Generator replacement for Generator BoneWelder 150-W1
Surgical Fusion Technologies GmbH
SupraFuser B Generator
Not in Commercial Distribution
- 07649990202204 ()
SF04-005-B
- Ultrasonic surgical system generator
No Description
Surgical Fusion Technologies GmbH
BoneWelder 150-W1
Not in Commercial Distribution
- 07649990202150 ()
BW04-001
- Ultrasonic surgical system generator
No Description
Surgical Fusion Technologies GmbH
SupraFuser Generator
In Commercial Distribution
- 07649990202075 ()
SF04-005
- Ultrasonic surgical system generator
Cutter Driver for Plaque Excision Systems
Covidien LP
FG02550
In Commercial Distribution
- 00821684043318 ()
- Mechanical atherectomy system catheter, peripheral
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050R Pulse Oximetry Sensor
In Commercial Distribution
- B595L2050R0 ()
- B595L2050R1 ()
- B595L2050R2 ()
L2050R
- Pulse oximeter probe, reusable
- Pulse Co-oximeter probe, reusable
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
L2050G Adapter
In Commercial Distribution
- B595L2050G0 ()
L2050G
- Cardiac arrhythmia monitoring system
- Wearable multiple vital physiological parameter monitoring system
The Vios Monitoring System (VMS) Adapter and Chest Sensor are intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-Lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure (NIBP) continuously and patient posture and activity. VMS allows for the input of body temperature and can display data from peripheral devices. VMS can generate alerts when rate-based cardiac arrhythmias are detected and when physiological vital signs fall outside of selected parameters.
The non-invasive blood pressure tracking is based on Pulse Arrival Time (PAT) which is obtained utilizing ECG and PPG signals, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. This feature is not intended for use in critical care environment.
VMS can also generate alerts when cardiac arrhythmias (Tachycardia, Bradycardia, Asystole, Ventricular Tachycardia/Ventricular Fibrillation and Atrial Fibrillation/Atrial Flutter) are detected.
The ECG rhythm analysis is intended for use by medically qualified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmia and medical interventions.
The VMS Adapter and Chest Sensor are intended to be used by Vios-trained clinical professionals who also have a working knowledge of medical procedures, practices, and terminology, as required for monitoring patients.
MURATA VIOS, INC.
CS2050 Chest Sensor
In Commercial Distribution
- B595CS20500 ()
- B595L2050G1 ()
CS2050
- Cardiac arrhythmia monitoring system
- Wearable multiple vital physiological parameter monitoring system
The Zeto ONE Head Unit is a detachable part of the Zeto ONE, which is an EEG system intended for prescription use in healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns.
The Head Unit component of the Zeto ONE is intended to hold electrodes on the subject's scalp and aquire electric signals produced by human brain activity.
ZETO INC
ZP-120-11011
In Commercial Distribution
- B675ONEHU1 ()
- Regular
- Small
- Electroencephalograph
Upper arm blood pressure monitor.
BODYTRACE, INC
BT104O
In Commercial Distribution
- B726BT104O2 ()
- B726BT104O1 ()
- B726BT104O0 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Upper arm blood pressure monitor.
BODYTRACE, INC
BT104
In Commercial Distribution
- B726BT1042 ()
- B726BT1041 ()
- B726BT1040 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Precision HD Camera for Lumos series light
SKYTRON LLC
B1-725-56
In Commercial Distribution
- 10841736123178 ()
- Surgical video camera
LED Surgical Light with center focus with optional camera capability
SKYTRON LLC
Lumos L5
In Commercial Distribution
- 10841736123161 ()
- Operating room light
An over the counter device indicated to emit energy in the red and IR region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
HOME SKINOVATIONS LTD
Supreme
In Commercial Distribution
- 00866057000314 ()
- 20866057000318 ()
- 10866057000311 ()
866057000314
- Cosmetic red-light phototherapy system, home-use
Iris AirShuttle™
Qfix
XT-5100-60
In Commercial Distribution
- 10841962118733 ()
XT-5100-60
- Patient lifting system stretcher
BoS™ AirShuttle™
Qfix
RT-5100-04
In Commercial Distribution
- 10841962111260 ()
RT-5100-04
- Patient lifting system stretcher
Portrait™ AirShuttle™
Qfix
RT-5100-02
In Commercial Distribution
- 10841962111253 ()
RT-5100-02
- Patient lifting system stretcher
Slate AirShuttle™
Qfix
RT-5100-01
In Commercial Distribution
- 10841962111246 ()
RT-5100-01
- Patient lifting system stretcher
AirDrive Trolley™
Qfix
RT-5100
In Commercial Distribution
- 10841962111239 ()
RT-5100
- Patient lifting system stretcher
Symphony™ Bos™ Transfer Device
Qfix
RT-5100-04
In Commercial Distribution
- 10841962110447 ()
RT-5100-04
- Patient lifting system stretcher
Symphony Portrait Head/Neck Transfer Device
Qfix
RT-5100-02
In Commercial Distribution
- 10841962109557 ()
RT-5100-02
- Patient lifting system stretcher
Symphony Standard Transfer Device
Qfix
RT-5100-01
In Commercial Distribution
- 10841962109540 ()
RT-5100-01
- Patient lifting system stretcher
Symphony™ Patient Trolley
Qfix
RT-5100
In Commercial Distribution
- 10841962109533 ()
RT-5100
- Patient lifting system stretcher
MasimoSET Masimo Headband
MASIMO CORPORATION
1608
In Commercial Distribution
- 10843997000373 ()
- 00843997000376 ()
1608
- Pulse oximeter probe, reusable
MasimoSET Standard Petite Wrap
MASIMO CORPORATION
1598
In Commercial Distribution
- 10843997000342 ()
- 00843997000345 ()
1598
- Dressing-fixation skin adhesive tape, non-silicone
MasimoSET Standard Multisite Wrap
MASIMO CORPORATION
1597
In Commercial Distribution
- 10843997000335 ()
- 00843997000338 ()
1597
- Dressing-fixation skin adhesive tape, non-silicone
MasimoSET® Cleanshield Multisite Wrap
MASIMO CORPORATION
1596
In Commercial Distribution
- 10843997000328 ()
- 00843997000321 ()
1596
- Dressing-fixation skin adhesive tape, non-silicone
Venue R3 final Assembly
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R3
In Commercial Distribution
- 00840682190510 ()
- General-purpose ultrasound imaging system
Venue Go R3 Final Assembly
GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
R3
In Commercial Distribution
- 00840682190503 ()
- General-purpose ultrasound imaging system
L4-20t-RS
GE Medical Systems (China) Co.,Ltd.
L4-20t-RS
In Commercial Distribution
- 00840682190299 ()
H48062AJ
- Extracorporeal ultrasound imaging transducer, hand-held
ASSY THERMAL RECORDER W/ PRINTER VALUE MONITOR(4TH EMC)
Ge Medical Systems Information Technologies, Inc.
B1X5-REC
In Commercial Distribution
- 00840682180689 ()
- Paper chart recorder