No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00887517399779 | 6942044 | CoRoent® XLR, 20x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
2 | 00887517399700 | 6941844 | CoRoent® XLR, 18x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
3 | 00887517399335 | 6941644 | CoRoent® XLR, 16x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
4 | 00887517398765 | 6941444 | CoRoent® XLR, 14x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
5 | 00887517398499 | 6941244 | CoRoent® XLR, 12x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
6 | 00887517398420 | 6941044 | CoRoent® XLR, 10x34x24 12° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
7 | 00887517398055 | 6932088 | CoRoent® XLR, 20x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
8 | 00887517397683 | 6931888 | CoRoent® XLR, 18x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
9 | 00887517397256 | 6931688 | CoRoent® XLR, 16x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
10 | 00887517396822 | 6931488 | CoRoent® XLR, 14x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
11 | 00887517396457 | 6931288 | CoRoent® XLR, 12x38x28 15° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
12 | 00887517395641 | 6922088 | CoRoent® XLR, 20x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
13 | 00887517395634 | 6922044 | CoRoent® XLR, 20x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
14 | 00887517395269 | 6921888 | CoRoent® XLR, 18x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
15 | 00887517395252 | 6921844 | CoRoent® XLR, 18x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
16 | 00887517394880 | 6921688 | CoRoent® XLR, 16x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
17 | 00887517394873 | 6921660 | CoRoent® XL Wide, 16x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
18 | 00887517394866 | 6921655 | CoRoent® XL Wide, 16x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
19 | 00887517394859 | 6921650 | CoRoent® XL Wide, 16x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
20 | 00887517394842 | 6921645 | CoRoent® XL Wide, 16x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
21 | 00887517394835 | 6921644 | CoRoent® XLR, 16x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
22 | 00887517394569 | 6921488 | CoRoent® XLR, 14x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
23 | 00887517394552 | 6921460 | CoRoent® XL Wide, 14x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
24 | 00887517394545 | 6921455 | CoRoent® XL Wide, 14x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
25 | 00887517394538 | 6921450 | CoRoent® XL Wide, 14x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
26 | 00887517394521 | 6921445 | CoRoent® XL Wide, 14x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
27 | 00887517394514 | 6921444 | CoRoent® XLR, 14x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
28 | 00887517394149 | 6921288 | CoRoent® XLR, 12x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
29 | 00887517394132 | 6921260 | CoRoent® XL Wide, 12x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
30 | 00887517394125 | 6921255 | CoRoent® XL Wide, 12x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
31 | 00887517394118 | 6921250 | CoRoent® XL Wide, 12x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
32 | 00887517394101 | 6921245 | CoRoent® XL Wide, 12x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
33 | 00887517393791 | 6921244 | CoRoent® XLR, 12x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
34 | 00887517393722 | 6921088 | CoRoent® XLR, 10x38x28 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
35 | 00887517393715 | 6921060 | CoRoent® XL Wide, 10x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
36 | 00887517393708 | 6921055 | CoRoent® XL Wide, 10x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
37 | 00887517393395 | 6921050 | CoRoent® XL Wide, 10x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
38 | 00887517393388 | 6921045 | CoRoent® XL Wide, 10x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
39 | 00887517393371 | 6921044 | CoRoent® XLR, 10x34x24 8° | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
40 | 00887517393333 | 6920860 | CoRoent® XL Wide, 8x22x60mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
41 | 00887517393326 | 6920855 | CoRoent® XL Wide, 8x22x55mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
42 | 00887517393319 | 6920850 | CoRoent® XL Wide, 8x22x50mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
43 | 00887517393302 | 6920845 | CoRoent® XL Wide, 8x22x45mm Lordotic | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
44 | 00887517392961 | 6916860 | CoRoent® XL, 16x18x60mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
45 | 00887517392954 | 6916855 | CoRoent® XL, 16x18x55mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
46 | 00887517392947 | 6916850 | CoRoent® XL, 16x18x50mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
47 | 00887517392930 | 6916845 | CoRoent® XL, 16x18x45mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
48 | 00887517392923 | 6916840 | CoRoent® XL, 16x18x40mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
49 | 00887517392916 | 6916260 | CoRoent® XL Wide, 16x22x60mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent | |
50 | 00887517392909 | 6916255 | CoRoent® XL Wide, 16x22x55mm | MAX | Intervertebral fusion device with bone graft, lumbar | 2 | CoRoent |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | G01900 | 06 | ThinkingNet | THINKING SYSTEMS CORPORATION | ||
2 | G012SW0028 | SW-0028 | Web application | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
3 | G012SW0027 | SW-0027 | Investigator application for Android | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
4 | G012SW0026 | SW-0026 | Sync application for Android | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
5 | G012SW0025 | SW-0025 | Link application for Android | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
6 | G012MC0015 | MC-0015 | MC-0015 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
7 | G012MC0014 | MC-0014 | MC-0014 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012B MC-0014 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
8 | G012MC0013 | MC-0013 | MC-0013 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
9 | G012MC0012 | MC-0012 | MC-0012 kit containing DIs G012BRCS02, G012BRCD02, BG012BRCP03, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
10 | G012MC0008 | MC-0008 | MC-0008 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
11 | G012MC0007 | MC-0007 | MC-0007 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012B MC-0007 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
12 | G012MC0006 | MC-0006 | MC-0006 kit containing DIs G012BRCS02, G012BRCD02, G012BRCP03, G012BSPS01, G012BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
13 | G012MC0005 | MC-0005 | MC-0005 kit containing DIs B493BRCS02, B493BRCD02, B493BRCP03, B493BSPS01, B493BRCA05 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
14 | G012MC0004 | MC-0004 | Discovery Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G01 Discovery Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G012BRCP03, G012BRCT01, G012BSPS01, G012BRCA05, G012MC0009 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
15 | G012MC0003 | MC0003 | Exploratory Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G Exploratory Kit containing DIs G012BRCS02, G012BRCD01, G012BRCP01, G012BRCP02, G012BRCP03, G012BRCT01,G012BSPS01, G012BRCA05, G0123MC0009 | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
16 | G012MC00022 | MC00022 | Clinical Investigations Kit containing BRCS02 Wearable Sensor Patch, BRCD02 Smar Clinical Investigations Kit containing BRCS02 Wearable Sensor Patch, BRCD02 Smart Charger, BSPS01 Medical Power Supply, BRCA05 Adhesive Applicator, BRCP03 Phone | BioStamp® nPoint | MEDIDATA SOLUTIONS, INC. | |
17 | G012BSPS01 | BSPS01 | Link Hub smart charger power supply | BioStamp® | MEDIDATA SOLUTIONS, INC. | |
18 | G012BRCT01 | BRCT01 | Mobile Application tablet | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
19 | G012BRCS02 | BRCS02 | Wearable sensor patch | BioStamp® | MEDIDATA SOLUTIONS, INC. | |
20 | G012BRCP03 | BRCP03 | Mobile phone application | BioStamp® | MEDIDATA SOLUTIONS, INC. | |
21 | G012BRCP02 | BRCP02 | Mobile application phone | BioStamp® nPoint | MEDIDATA SOLUTIONS, INC. | |
22 | G012BRCP01 | BRCP01 | Mobile application phone | BioStamp nPoint™ | MEDIDATA SOLUTIONS, INC. | |
23 | G012BRCD02 | BRCD02 | Link Hub Smart Charger | BioStamp® | MEDIDATA SOLUTIONS, INC. | |
24 | G012BRCA05 | BRCA05 | Adhesive Applicator | BioStamp® | MEDIDATA SOLUTIONS, INC. | |
25 | G012BRCA02 | BRCA02 | Adhesive with hydrogel | BioStamp® nPoint | MEDIDATA SOLUTIONS, INC. | |
26 | G003DM01 | 1 | 3D printed patient specific replicas of patient anatomy | 3D Anatomic Model | RICOH USA, INC. | |
27 | EZIEZIEHMVISIONRFD3D1 | 302837 | Ziehm Vision RFD 3D | ZIEHM IMAGING GMBH | ||
28 | EZIEZIEHMVISIONRFD3D1 | 302837 | Ziehm Vision RFD 3D | ZIEHM IMAGING GMBH | ||
29 | EZIEZIEHMVISIONRFD1 | 302801 | Ziehm Vision RFD | ZIEHM IMAGING GMBH | ||
30 | EZIEZIEHMVISIONRFD1 | 302801 | Ziehm Vision RFD | ZIEHM IMAGING GMBH | ||
31 | EZIEZIEHMVISIONR1 | 302805 | Ziehm Vision R | ZIEHM IMAGING GMBH | ||
32 | EZIEZIEHMVISIONR1 | 302805 | Ziehm Vision R | ZIEHM IMAGING GMBH | ||
33 | EZIEZIEHMVISIONFD165 | 302891; 302929 | Ziehm Vision FD | ZIEHM IMAGING GMBH | ||
34 | EZIEZIEHMVISIONFD165 | 302891; 302929 | Ziehm Vision FD | ZIEHM IMAGING GMBH | ||
35 | EZIEZIEHMSOLOFD1 | 132874 | Ziehm Solo FD | ZIEHM IMAGING GMBH | ||
36 | EZIEZIEHMSOLOFD1 | 132874 | Ziehm Solo FD | ZIEHM IMAGING GMBH | ||
37 | EZIEZIEHMSOLO1 | 302711 | Ziehm Solo | ZIEHM IMAGING GMBH | ||
38 | EZIEZIEHMSOLO1 | 302711 | Ziehm Solo | ZIEHM IMAGING GMBH | ||
39 | EZIEZIEHM8000 | 308000 | Ziehm 8000 | ZIEHM IMAGING GMBH | ||
40 | EZIEZIEHM8000 | 308000 | Ziehm 8000 | ZIEHM IMAGING GMBH | ||
41 | EOLEOLEASPHEREV3P01 | 3.0 | Olea Sphere V3.0 is an image processing software package to be used by trained p Olea Sphere V3.0 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | OLEA SPHERE | OLEA MEDICAL USA | |
42 | EOLEOLEASPHEREV2P31 | 2.3 | Olea Sphere V2.3 is an image processing software package to be used by trained p Olea Sphere V2.3 is an image processing software package to be used by trained professionals including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" workstation and can be used to perform image viewing, processing, image collage and analysis of medical images. Data and images are acquired through DICOM compliant imaging devices and modalities. | OLEA SPHERE | OLEA MEDICAL USA | |
43 | EOLEFMRIV1P00 | V1.0 | Functional MR V1.0 is an optional image processing software application that is Functional MR V1.0 is an optional image processing software application that is intended for use on Olea Sphere® V3.0 software package. It is intended to be used by trained professionals including, but not limited to, physicians, MR technicians, radiographers.Functional MR V1.0 includes a software module that computes the activation map from a BOLD sequence and supports the visualization, analysis of activation maps. Functional MR V1.0 can also be used to provide reproducible measurements of derived maps. These measurements include thresholds modification and ROI analysis.Functional MR V1.0 may also be used as an image viewer of multi-modality digital images, including BOLD and DTI images. | FUNCTIONAL MR | OLEA MEDICAL USA | |
44 | EOLEBREASTSCAPEV1P00 | V1.0 | breastscape V1.0 is an optional image processing software application that is in breastscape V1.0 is an optional image processing software application that is intended for use on Olea Sphere V3.0 software package cleared under K152602. It is intended to be used by trained breast imaging physicians and trained MRI technologists.breastscape V1.0 includes 2 software modules :- BreastApp supports the visualization, analysis, and reporting of lesions measurements and analysis.- BreastLoc to assist users in planning MR guided breast interventional procedures.Data and images are acquired through DICOM compliant imaging devices and modalities. | BREASTSCAPE | OLEA MEDICAL USA | |
45 | 04260361440204 | TTA2.51 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures andfunction based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to beused for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
46 | 04260361440198 | TTA2.42 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
47 | 04260361440181 | TTA2.50 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
48 | 04260361440174 | TTA2.41 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TOMTEC-ARENA is not intended to be used for reading of mammography images. Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
49 | 04260361440167 | TTA2.40 | TOMTEC-ARENA software is a clinical software package designed for review, quanti TOMTEC-ARENA software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.TOMTEC-ARENA is not intended to be used for reading of mammography images.Indications for use of TOMTEC-ARENA software are quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis. | TOMTEC-ARENA | TOMTEC IMAGING SYSTEMS GMBH | |
50 | 04260361440150 | IA4 | The IMAGE-ARENA software platform is intended to import, export, store, retrieve The IMAGE-ARENA software platform is intended to import, export, store, retrieve and report digital studies. The IMAGE-ARENA software can import certain digital 2D or 3D image file formats of different modalities. IMAGE-ARENA offers a Generic Clinical Application Package interface in order to connect TOMTEC applications as well as commercially available analysis and quantification tools to the IMAGE-ARENA platform. It is intended as a general purpose digital medical image processing tool.IMAGE-ARENA is not intended to be used for reading of mammography images. | IMAGE-ARENA | TOMTEC IMAGING SYSTEMS GMBH |