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The Overa® test is a qualitative serum test that combines the results of five immunoassays into a single numeric result. It is indicated for women who meet the following criteria: over age 18, ovarian adnexal mass present for which surgery is planned, and not yet referred to an oncologist. The Overa® test is intended to aid in assessing whether a woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy as part of the preoperative evaluation. The Overa® test must be interpreted in conjunction with an independent clinical and imaging evaluation. The test is not intended as a screening or stand-alone diagnostic assay.
Aspira Women's Health Inc.
4.0.0
In Commercial Distribution
- 00860942000106 ()
- Medical equipment clinical data interfacing software
This is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Maude Group, Inc.
55761
In Commercial Distribution
- 10860773000471 ()
- 00860773000474 ()
MD-SHNS-2
- Sexual lubricant
This is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Maude Group, Inc.
55762
In Commercial Distribution
- 00860773000436 ()
- 10860773000433 ()
- 20860773000430 ()
MD-SHNS-8
- Sexual lubricant
1" x 60yd Autoclave Tape 3 rolls
NEVS INK, INC.
TC-auto-1
In Commercial Distribution
- 00860671000323 ()
- 00860671000309 ()
TC-auto-1
- Chemical/physical sterilization process indicator
The Regulated Software Application (RSA) is a system of co-dependent web based computer programs, used to manage and support all aspects of their blood banking processes. This system encapsulates the data access and business rules necessary for enabling blood collections, manufacturing, labeling, and distribution management efforts. Additionally, certain modules have associated administration function that creates traceability and accountability for every step of the blood banking process. The system utilizes technology standards that provide the robustness necessary for supporting web-enabled applications that interface with disparate systems. The application has been developed in a modular format.
ONEBLOOD, INC.
1.0.19.0
Not in Commercial Distribution
- 00860664000309 ()
1.0.19.0
- Blood bank information system application software
No Description
ROHRER AESTHETICS, LLC
Spectrum
In Commercial Distribution
- 00860564000317 ()
- Multi-modality skin surface treatment system generator
No Description
PRO-DEX, INC.
05.000.020LN
In Commercial Distribution
- 00860540000225 ()
- Bone/joint surgical power tool motorized handpiece/set, electric, reusable
Family Healthware™ is a self-administered, interactive Web-based software tool that assesses a person's familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer). It provides users with a "prevention plan" containing personalized recommendations for lifestyle changes and screening. For each person, the tool collects data about the following:
+ Health behaviors (e.g., smoking and exercise);
+ Screening tests (e.g., blood cholesterol and mammography);
+ Health history among his or her first- and second-degree relatives.
One set of algorithms in the software analyzes users' family history data and assesses their familial risk for each of the six diseases. A second set of algorithms uses the data on familial risk, health behaviors, and screening results to generate personalized prevention messages.
The intended use is to utilize computerized family genomic data to increase disease risk perceptions and improve chronic disease management, thereby reducing the effects of these serious chronic disorders.
SANITAS, INC.
Version 2.0 Released 20160615
Not in Commercial Distribution
- 00860508000304 ()
- Self-care monitoring/reporting software
No Description
EPIC SYSTEMS CORPORATION
1
In Commercial Distribution
- 00860475000383 ()
- Wound management image-analysis software
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
9
In Commercial Distribution
- 00860461001783 ()
FG0064
- Dental milling system, CAD/CAM, laboratory
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
10
In Commercial Distribution
- 00860461001776 ()
FG0064
- Dental milling system, CAD/CAM, laboratory
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Ulab Systems, Inc.
8
In Commercial Distribution
- 00860461001769 ()
FG0064
- Dental milling system, CAD/CAM, laboratory
The uLab Systems uDesign is orthodontic diagnosis and treatment simulation software for use by dental professionals. uDesign imports patient 3-D digital scans and allows the user to diagnose the orthodontic treatment needs of the patient and rapidly develop a treatment plan. The output of the treatment plan may be downloaded as files in standard stereolithographic (STL) format for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers
Ulab Systems, Inc.
Version 2.2
Not in Commercial Distribution
- 00860461001707 ()
FG0064
- Dental milling system, CAD/CAM, laboratory
The C-5000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer
TITRONICS RESEARCH & DEVELOPMENT COMPANY
C-5000
In Commercial Distribution
- 00860447001738 ()
- Thermographic camera
The C-7000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer
TITRONICS RESEARCH & DEVELOPMENT COMPANY
Tytron C-7000
In Commercial Distribution
- 00860447001714 ()
- Thermographic camera
The C-5000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer
TITRONICS RESEARCH & DEVELOPMENT COMPANY
Tytron C-5000
Not in Commercial Distribution
- 00860447001707 ()
- Thermographic camera
Pneumatic plethysmograph.
ACI MEDICAL LLC
APG-1000
In Commercial Distribution
- 00860446000312 ()
APG-1000
- Limb plethysmograph
The Epinephrine Convenience Kit contains a vial of Epinephrine 1mg/mL (1:1000) and two (2) Certa Dose Epinephrine Syringe Devices that are modifications of an existing and commonly used syringe device. The Certa Dose Epinephrine Syringe Device started as an unlabeled off the shelf 3/10 mL syringe that has been modified to use mL graduation marks with color zones that align with color zones that correspond to pediatric weight ranges that can be used as a secondary confirmation that measured volumes are within ranges that are common for a patient’s weight. The Kit is intended for use in clinical and emergency medical settings to assist healthcare professionals and emergency medical personnel in measuring a desired volume of epinephrine for delivery to pediatric patients.
CERTA DOSE, INC.
1
In Commercial Distribution
- 00860425001606 ()
- 00860425001613 ()
- 10860425001603 ()
- Total Volume: .3 Milliliter
- Length: .5 Inch
- Needle Gauge: 29 Gauge
CD-EPI-001
- General-purpose syringe/needle
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution
- 00860424000297 ()
PSP-111
- Tendon graft
No Description
JOINT RESTORATION FOUNDATION INC
1
In Commercial Distribution
- 00860424000280 ()
PSP-091
- Tendon graft