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BONE ACCESS TOOLS VPT13B 13GA BEVEL
MEDTRONIC SOFAMOR DANEK, INC.
VPT13B
Not in Commercial Distribution
- 00643169637474 ()
- Bone access channel kit
ASCB Installation Tools and Hardware Kit
ATRICURE, INC.
ASCB
In Commercial Distribution
- 00818354016444 ()
A000810
- Instrument trolley
MGUIDE tools kit for int. hex.
MIS Implants Technologies Ltd.
MG-KT01
In Commercial Distribution
- 07290109013596 ()
MG-KT01
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable
BONE ACCESS TOOLS VPT13B 13GA BEVEL
MEDTRONIC SOFAMOR DANEK, INC.
VPT13B
In Commercial Distribution
- 00763000311858 ()
- Bone access channel kit
BONE ACCESS TOOLS VPT13B 13GA BEVEL
MEDTRONIC SOFAMOR DANEK, INC.
VPT13B
In Commercial Distribution
- 00763000026813 ()
- Bone access channel kit
iSy® Re-Set Removal tools set
ALTATEC GmbH
P5900.1000
In Commercial Distribution
- E219P590010001 ()
P5900.1000
- Dental implant extractor
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11149925
Not in Commercial Distribution
- 04056869006833 ()
- Radiological PACS software
Actical Software Global
Respironics, Inc.
3.11
In Commercial Distribution
- 00606959021013 ()
1081738
- Kinesiology ambulatory recorder
No Description
OTODYNAMICS LIMITED
ILOv6
In Commercial Distribution
- 05060396170713 ()
- Otoacoustic emission system, line-powered
No Description
OTODYNAMICS LIMITED
EZ-Screen
In Commercial Distribution
- 05060396170706 ()
- Otoacoustic emission system, line-powered
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together.
The zensor+ software allows review of all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician.
The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0811
In Commercial Distribution
- 05060484630051 ()
- Electrocardiography telemetric monitoring system
The zensor software system is a web and PC based tool assisting clinicians in managing patients being monitored with Intelesens' medical devices. The web and PC components of the software can be configured to be used individually or together.
The zensoronline software has the option to receive wirelessly transmitted pre-defined event alerts from the Intelesens' monitoring device for review by healthcare practitioners and/or review all physiological data that has been previously stored and downloaded from the monitoring device for later analysis by a clinician.
The system is intended to be used to obtain physiological readings for use in routine check-ups. Any events or variations in physiological readings are not intended to be used to summon emergency care.
INTELESENS LIMITED
PN0810
In Commercial Distribution
- 05060484630044 ()
- Electrocardiography telemetric monitoring system
Aurix software for use with the Aurix system (DI: 00627908080011)
The UDI for software is comprised of the following:
GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version)
UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA002
Not in Commercial Distribution
- 00627908090027 ()
- Evoked-potential audiometer
Integrity software for use with the first generation Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system
(DI: 00627908020017).
The UDI is comprised of the following:
GTIN + Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) (which represents the software version)
UDI Application Identifier for Additional Product Identification Assigned by the Manufacturer (ADDITIONAL ID) = 240
Vivosonic Inc
SWA001
In Commercial Distribution
- 00627908090010 ()
- Otoacoustic emission system, battery-powered
- Evoked-potential audiometer
The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution
- 00860001218275 ()
SFW-2012
- Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
No Description
Norland at Swissray
4
In Commercial Distribution
- 00866955000478 ()
- Basic diagnostic x-ray system operation software
No Description
WAHTS HEARING LLC
0.X.X
In Commercial Distribution
- 00860005068319 ()
- Tone audiometer
Breathing therapy Biofeedback System
ACCELERATED CARE PLUS CORP
FlowSoftware
In Commercial Distribution
- 00858703006313 ()
- Bioelectrical signal analysis software
Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases.
BLACKROCK NEUROMED, LLC
RS-0003
In Commercial Distribution
- 00850154007086 ()
RS-0003
- Electroencephalography telemetric monitoring system
- Bioelectrical signal analysis software
SeeMore Software 4.4.x
INTERSON CORP
4.4.x
In Commercial Distribution
- 00850921007172 ()
- Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 4.2.1 Urology
INTERSON CORP
4.2.1 URO
In Commercial Distribution
- 00850921007165 ()
98-3528-03
- Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 4.2.1 Generic
INTERSON CORP
4.2.1 GEN
In Commercial Distribution
- 00850921007158 ()
98-3528-02
- Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 4.2.1 OB GYN
INTERSON CORP
4.2.1 OB GYN
In Commercial Distribution
- 00850921007141 ()
98-3528-01
- Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 2.0.03 OB GYN
INTERSON CORP
2.0.03 OB GYN
In Commercial Distribution
- 00850921007110 ()
98-3517-03
- Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 2.0.03 Generic
INTERSON CORP
2.0.03 GEN
In Commercial Distribution
- 00850921007103 ()
98-3517-00
- Extracorporeal ultrasound imaging transducer, hand-held
SeeMore Software 2.0.03 Urology
INTERSON CORP
2.0.03 URO
In Commercial Distribution
- 00850921007066 ()
98-3517-02
- Extracorporeal ultrasound imaging transducer, hand-held
Software used for the interaction and programming of the Novi Device.
SCOTTCARE CORPORATION, THE
Novi Software
In Commercial Distribution
- 00856298006237 ()
101633
- Electrocardiographic long-term ambulatory recording analyser application software
Software used for interaction and programming of the TeleSenseRCM and TeleSense-E devices.
SCOTTCARE CORPORATION, THE
TeleSense Software
In Commercial Distribution
- 00856298006213 ()
- Electrocardiographic long-term ambulatory recording analyser application software
Supplemental Software provided on a thumb drive. Enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014300-000
Not in Commercial Distribution
- 00856264005776 ()
014300
- Retinal prosthesis system tester/clinical evaluator
The WAW Duo FUE System is intended for Follicular Unit Extraction (FUE) with the aim to harvest hair follicles
by preserving hair integrity (amount of hair per follicle and hair quality) for further hair graft implantation. This
is done by optimizing hair transplant for both the receiver (increasing quality of the recipient area with respect
to naturalness and density) and the donor (taking care of the donor region).
The WAW Duo FUE System is composed of the following:
- The WAW Wireless Handpiece:
o Composed of a motor and a battery, and a detachable cleanable (via autoclave) external
sleeve
o Connected via Bluetooth to the tablet
o Responsible for the rotation and oscillation movements of the punch (not included) for the
FUE,
- The WAW Wired Handpiece, a backup solution for the WAW Wireless Handpiece:
o Cleanable (via autoclave)
o Connected via a wire to the pedal
o Responsible for the rotation and oscillation movements of the punch for the FUE,
- The WAW Pedal, responsible for activating the handpieces,
- The WAW Software, responsible for defining the parameters of functioning (rotation and
oscillation movement) of the handpieces and mode (manual, semi-auto, auto or continuous) of the
pedal (the Samsung tablet is supplied),
- The WAW Charging Station, intended to recharge the wireless handpiece and
- The External Sleeve Support Box, intended to sustain external parts of WAW Wireless
Handpiece and WAW Wired Handpiece during autoclave process.
- Assembly tools: 3 mounting tools to assemble and disassemble the handpieces.
Devroye Instruments Belgium
0.1.35
In Commercial Distribution
- 05430003362068 ()
- Electrosurgical handpiece, reusable
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M815000
In Commercial Distribution
- 00817020020884 ()
- Visual-reinforcement audiometer
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M817000
In Commercial Distribution
- 00817020020877 ()
- Tone audiometer
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M814000
In Commercial Distribution
- 00817020020860 ()
- Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M813000
In Commercial Distribution
- 00817020020853 ()
- Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811007
In Commercial Distribution
- 00817020020815 ()
- Bioelectrical signal analysis software
No Description
INTELLIGENT HEARING SYSTEMS CORP.
M811000
In Commercial Distribution
- 00817020020808 ()
- Bioelectrical signal analysis software
No Description
Haag-Streit AG
i9.0
In Commercial Distribution
- 07640132987256 ()
- Medical image management system
No Description
Haag-Streit AG
i8.2
In Commercial Distribution
- 07640132986105 ()
- Medical image management system
"ANS1 Software is inetended for use: ANS1 Software is an optional software accessory for use with the following models with datamanagement capabilities: a) TM-Oxi (Oximeter and blood pressure device) and b) SudoPath
(Galvanic Skin response) and c) ES-BC (Body Composition Analyzer).When used in combination with TM-Oxi and/or SudoPath, and/or ES-BC devices, the ANS1software uploads the data of the devices, analyzes the data, and then displays the data in ac omputer for enhanced data management.
The ANS1 software is intended for use in clinical settings as an aid for health careprofessionals to review, analyze, and evaluate the historical tests results."
LD TECHNOLOGY, LLC
G001
In Commercial Distribution
- B322G0011 ()
- Manual-inflation electronic sphygmomanometer, non-portable
- Skin electrical conductance meter
Software with CardioStation
UNIVERSAL MEDICAL, INC.
eCardiostation Software
In Commercial Distribution
- B147EC0 ()
- Electrocardiography telemetric monitoring system
No Description
BRAEMAR MANUFACTURING, LLC
900-0621-02
In Commercial Distribution
- B146C4MA020 ()
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0621-00
In Commercial Distribution
- B146C4MA000 ()
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0620-08
In Commercial Distribution
- B146C3MA080 ()
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0620-07
In Commercial Distribution
- B146C3MA070 ()
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0620-05
In Commercial Distribution
- B146C3MA050 ()
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0620-02
In Commercial Distribution
- B146C3MA020 ()
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0620-00
In Commercial Distribution
- B146C3MA00 ()
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0619-08
In Commercial Distribution
- B146C2MA080 ()
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0619-00
In Commercial Distribution
- B146C2MA000 ()
- Electrocardiographic long-term ambulatory recording analyser application software
No Description
BRAEMAR MANUFACTURING, LLC
900-0618-08
In Commercial Distribution
- B146C1MA080 ()
- Electrocardiographic long-term ambulatory recording analyser application software