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Headphone portion for Salux™ Tablet-Controlled Audiometer. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-HP-01
In Commercial Distribution
- 00860007826610 ()
SALUX-HP-01
- Tone audiometer, semi-automated
Bluetooth audiometer portion of Salux™ Tablet-Controlled Audiometer. The Examinetics Tablet-Controlled Audiometer is an audiometer designed to be compliant with ANSI Standard 3.6. The Salux™ Audiometer will have the ability to interface with other software necessary for administering hearing screenings. The Salux™ Audiometer solution can be used to display video or static content to the participant.
Examinetics, Inc.
SALUX-AU-01
In Commercial Distribution
- 00860007826603 ()
SALUX-AU-01
- Tone audiometer, semi-automated
No Description
Solace Trading LLC
CL8032 - X-Large - 100 PCS
In Commercial Distribution
- 00860007772337 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Solace Trading LLC
CL8032 - Large - 100 PCS
In Commercial Distribution
- 00860007772320 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Solace Trading LLC
CL8032 - Medium - 100 PCS
In Commercial Distribution
- 00860007772313 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
No Description
Solace Trading LLC
CL8032 - Small - 100 PCS
In Commercial Distribution
- 00860007772306 ()
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Portable, 12-lead ECG testing kit.
Mg Medical Products LLC
1
In Commercial Distribution
- 00860007764424 ()
EPSK001CLPA020MG
- Electrocardiograph, professional, single-channel
StitchStand Graft Preparation Set
Winter Innovations Inc.
SS-100
In Commercial Distribution
- 00860007711213 ()
- Tendon/ligament graft preparation station
P2: A “P2” dental hand-bur handle, is a "premium" locking-handle which consists of a round, threaded, aluminum handle which embodies a heavy-duty micro-chuck assembly (MCA). The MCA embodies a threaded end which screws into the handle’s internal threads in order to secure a dental bur so it cannot dislodge while in use. To secure a dental bur after insertion, a bur-locking-wrench grips the MCA and is counter-tightened by a locking pin at the handle’s opposite end. The MCA’s outer sleeve embodies two locking grooves (or slots) that engage a 7 mm bur-locking “wrench” or “key.” The casing is made of durable, 2 mm 6061-T6 medical grade aluminum designed for maximum strength and longevity. Rightly classed as a “premium” model, it can withstand the demands of repeated bur-tightening common to a busy dental practice engaged in chair-side bur changing. Learn more about our mission at dentalcareforall.org. If you have any complaints with our products please call or email us for immediate resolution: email team@dcfai.org / Call +19562801708 (WhatsApp)
DENTAL CARE FOR ALL INTERNATIONAL
P2
In Commercial Distribution
- 00860007700804 ()
- 00860007700828 ()
- Dental excavator, reusable
Laser Fiber Borst Silicone Inserts (100)
Sentient Manufacturing, LLC
3041140
In Commercial Distribution
- 00860007603785 ()
- 00860008856418 ()
- General/multiple surgical laser system beam guide, single-use
Sentient Manufacturing Laser Fiber Stripper Blades
Sentient Manufacturing, LLC
3041350
In Commercial Distribution
- 00860007603761 ()
- Laser fibre stripper
Sentient Manufacturing Laser Fiber Stripper
Sentient Manufacturing, LLC
3041340
Not in Commercial Distribution
- 00860007603754 ()
- Laser fibre stripper
Paige Prostate is a software only device intended to assist pathologists in the detection of foci that are suspicious for cancer during the review of scanned whole slide images (WSI) from prostate needle biopsies prepared from hematoxylin & eosin (H&E) stained formalin-fixed paraffin embedded (FFPE) tissue. After initial diagnostic review of the WSI by the pathologist, if Paige Prostate detects tissue morphology suspicious for cancer, it provides coordinates (X,Y) on a single location on the image with the highest likelihood of having cancer for further review by the pathologist.
PAIGE.AI, INC.
1.X
In Commercial Distribution
- 00860007599118 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD
Le Fort Surgical Guide - Wall with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543494 ()
GCLPFBC
- Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots with Splints - Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543487 ()
GCLRFBC
- Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Wall Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543470 ()
GCLPBC
- Custom-made orthopaedic/craniofacial surgical guide
Le Fort Surgical Guide - Slots Resin
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543463 ()
GCLRBC
- Custom-made orthopaedic/craniofacial surgical guide
Final Orthognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543456 ()
FFCOBC
- Custom-made orthopaedic/craniofacial surgical guide
Intermediate Orhognathic Surgical Splint
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543449 ()
FICOBC
- Custom-made orthopaedic/craniofacial surgical guide
Maxillomandibular Anatomic Diagnostic Model CL
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543432 ()
MAPMMCL
- Custom-made organ/bone anatomy model
Patient-Specific Maxillofacial/midface implant-Ti
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543425 ()
BETMCT
- Custom-made cranial bone prosthesis
Patient-Specific Maxillary Implant - Titanium - high complexity
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543418 ()
BEACMXT
- Custom-made cranial bone prosthesis
Patient-Specific Mandible Implant - Titanium - high complexity
Techfit Digital Surgery, Inc.
0
In Commercial Distribution
- 00860007543401 ()
BEACMT
- Custom-made cranial bone prosthesis
The CogNet AI-MT is a standalone software medical device for screening FFDM mammograms. This software is a triage device that allows the result to be prioritized for viewing by a qualified radiologist.
Medcognetics Inc
MT
In Commercial Distribution
- 00860007434709 ()
- X-ray image interpretive software
The Low Ejection Fraction AI-ECG Algorithm interprets 12-lead ECG voltage times series data using an artificial intelligence-based algorithm. The device analyzes 10 seconds of a single 12-lead ECG acquisition, and within seconds provides a prediction of likelihood of LVEF (ejection fraction less than or equal to 40%) to third party software. The results are displayed by the thirdparty software on a device such as a smartphone, tablet, or PC. The Low Ejection Fraction AIECG Algorithm was trained to predict Low LVEF using positive and control cohorts, and the prediction of Low LVEF in patients is generated using defined conditions and covariates.
The Low Ejection Fraction AI-ECG Algorithm device is intended to address the unmet need for a point-of-care screen for LVEF less than or equal to 40% and is expected to be used by cardiologists, front-line clinicians at primary care, urgent care, and emergency care settings, where cardiac imaging may not be available or may be difficult or unreliable for clinicians to operate. Clinicians will use the Low Ejection Fraction AI-ECG Algorithm to aid in screening for LVEF less than or equal to 40% and making a decision for further cardiac evaluation.
Anumana, Inc.
v.2.2.0 (1010)
In Commercial Distribution
- 00860007426407 ()
- Cardiopulmonary physiological parameter analysis software
TrueFit Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of Polyamide (PA12).
Adaptiiv Medical Technologies Inc
N/A
In Commercial Distribution
- 10860007402385 ()
- 00860007402388 ()
- Radiation therapy bolus, single-use
TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit.
The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of silicone.
Adaptiiv Medical Technologies Inc
NA
In Commercial Distribution
- 00860007402340 ()
ADPT-ONDEM-3DPRT-SIL
- Radiation therapy bolus, single-use
Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of external beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. The desired external beam radiation therapy accessories will be printed using HP Jet Fusion 5200 Series 3D Printing Solution and Ultrasint® Thermoplastic polyurethane (TPU01) powder.
Adaptiiv Medical Technologies Inc
N/A
In Commercial Distribution
- 10860007402330 ()
- 00860007402333 ()
ADPT-ONDEM-3DPRT
- Radiation therapy bolus, single-use
3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution
- 00860007402326 ()
- Radiation therapy software
3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy. The use of 3D Bolus application is by prescription only.
Adaptiiv Medical Technologies Inc
v2021.1.0
In Commercial Distribution
- 00860007402319 ()
- Radiation therapy software
3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.
Adaptiiv Medical Technologies Inc
v3.0.0
In Commercial Distribution
- 00860007402302 ()
- Radiation therapy software
ADIMS is a stand-alone blood establishment computer software application (BECS) that provides for the management of plasma and whole blood donors for an RBC immunization program as well as the record and inventory management of immunogen red blood cells. The application is used to determine donor eligibility and release of the blood or blood component for transfusion as well as tracking the preparation of immunogen components (vials) for storage and distribution. Additionally, ADIMS allows for the tracking the recipient of transfused immunogen RBCs
Csl Plasma Inc.
1.0
In Commercial Distribution
- 00860007397615 ()
- Blood bank information system application software
No Description
Qr8 Health Inc
CHR-COG-20
In Commercial Distribution
- 00860007318795 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-W20
In Commercial Distribution
- 00860007318788 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-23
In Commercial Distribution
- 00860007318771 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-21
In Commercial Distribution
- 00860007318764 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-22
In Commercial Distribution
- 00860007318757 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
SNP-GOG-21
Not in Commercial Distribution
- 00860007318740 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-10
Not in Commercial Distribution
- 00860007318733 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
CHR-COG-W10
Not in Commercial Distribution
- 00860007318726 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-20
Not in Commercial Distribution
- 00860007318719 ()
- Cognitive assessment software
No Description
Qr8 Health Inc
SNP-COG-10
Not in Commercial Distribution
- 00860007318702 ()
- Cognitive assessment software
No Description
Hangzhou Universal Electronic Co.,Ltd.
9500
In Commercial Distribution
- 00860007291128 ()
- Intermittent electronic patient thermometer
No Description
Ellis Instruments Inc
#125-815
In Commercial Distribution
- 00860007290664 ()
- Surgical implant handling forceps
No Description
Ellis Instruments Inc
#125-080
In Commercial Distribution
- 00860007290640 ()
- Surgical implant handling forceps
No Description
Ellis Instruments Inc
#125-025
In Commercial Distribution
- 00860007290626 ()
- Surgical implant handling forceps
No Description
Ellis Instruments Inc
#125-024
In Commercial Distribution
- 00860007290602 ()
- Surgical implant handling forceps
Canvas Dx is a prescription diagnostic aid to healthcare professionals (HCP) considering the diagnosis of Autism Spectrum Disorder (ASD) in patients 18 months through 72 months of age at risk for developmental delay. The patient’s caregiver uses a smartphone application (“App”) to fill out a caregiver questionnaire and to make video recordings of behavior at home, and then the physician fills out a medical questionnaire online. The results are made available to the physician.
Cognoa, Inc.
1.3.0
In Commercial Distribution
- 00860007260605 ()
- Neurodevelopmental disorder interpretive software
Oscillating Saw Packaged Assembly
Insurgical, Inc.
320-0067-001
In Commercial Distribution
- 00860007230035 ()
3010002
- Bone/joint surgical power tool motorized handpiece/set, electric, single-use
Reciprocating Saw Packaged Assembly
Insurgical, Inc.
320-0071-001
In Commercial Distribution
- 00860007230028 ()
3010003
- Bone/joint surgical power tool motorized handpiece/set, electric, single-use