| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 07332747149319 | 300516 | 300516 | Occlusion Guide Trefoil | NDP | Accessories, implant, dental, endosseous | 1 | Trefoil™ |
| 2 | 07332747113730 | 38738 | 38738 | On1 IOS Healing Cap 5 mm WP | NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 2 | On1™ |
| 3 | 07332747034882 | 36720 | 36720 | Implant Driver CC RP 28mm | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 4 | 07332747096224 | 38177 | 38177 | Gold Cylinder 4mm | DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM | 2 | NA |
| 5 | 07332747016529 | 6129 | 6129 | Implant Analog 6.0 HL/RPL | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 6 | 07332747014303 | 36117 | 36117 | Drill Tapered 2 mm | DZI | DRILL, BONE, POWERED | 2 | NobelReplace® |
| 7 | 07332747009040 | 29163 | 29163 | Screwdriver/Activator | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 8 | 07332747005820 | 33081 | 33081 | Drill Stop Ø4.2 | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 9 | 07332747000306 | 34554 | 34554 | Abutment screw PS WP-RP | NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | 2 | NA |
| 10 | 17332747008125 | 38857 | 38857 | Protection Analog / Drill Guide CC WP 5/pkg | NDP | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | NA | |
| 11 | 17332747008118 | 38856 | 38856 | Protection Analog / Drill Guide CC RP 5/pkg | NDP | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | NA | |
| 12 | 17332747008101 | 38855 | 38855 | Protection Analog / Drill Guide CC NP 5/pkg | NDP | ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS | NA | |
| 13 | 17332747007975 | 38919 | 38919 | Multi-unit Abutment Plus Replica (5pkg) | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 14 | 17332747000211 | 29499 | 29499 | Implant Replica NobRpl NP 20/pkg | NDP | Accessories, implant, dental, endosseous | NobelReplace® | |
| 15 | 17332747001805 | 36804 | 36804 | Protection Analog CC 3.0 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 16 | 17332747001027 | 2413 | 2413 | Retainer Ring 2/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 17 | 17332747000976 | 61760 | 61760 | O-Ring for Tools 2 sets of 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 18 | 17332747000969 | 2078 | 2078 | O-Ring Clinical White 12/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 19 | 17332747000952 | 2493 | 2493 | O-Ring Abutment Analog w Spacer 2/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 20 | 17332747000402 | 62200 | 62200 | Abutment Scr, Slotted, 3.25HL/3.5, 4-Pk | NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | NA | |
| 21 | 17332747000266 | 30043 | 30043 | Protection Analog NobRpl 6.0 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 22 | 17332747000235 | 29503 | 29503 | Implant Replica NobRpl WP 20/pkg | NDP | Accessories, implant, dental, endosseous | NobelReplace® | |
| 23 | 17332747000228 | 29501 | 29501 | Implant Replica NobRpl RP 20/pkg | NDP | Accessories, implant, dental, endosseous | NobelReplace® | |
| 24 | 17332747000174 | 29293 | 29293 | Lab Screw Implant Level NobRpl RP/WP/6.0 5/pkg | NDP | Accessories, implant, dental, endosseous | NobelReplace® | |
| 25 | 17332747000167 | 29290 | 29290 | Lab Screw Implant Level Bmk Syst RP 5pkg | NDP | Accessories, implant, dental, endosseous | 1 | Brånemark System® |
| 26 | 17332747000150 | 29287 | 29287 | Lab Screw Multi-unit 5/pkg | NDP | Accessories, implant, dental, endosseous | NA | |
| 27 | 17332747000143 | 29124 | 29124 | Protection Analog M-u Bmk Syst WP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | Brånemark System® |
| 28 | 17332747000136 | 29123 | 29123 | Protection Analog Multi-unit 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 29 | 17332747000129 | 29121 | 29121 | Protection Analog NobRpl WP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 30 | 17332747000112 | 29120 | 29120 | Protection Analog NobRpl RP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 31 | 17332747000105 | 29119 | 29119 | Protection Analog NobRpl NP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 32 | 17332747000099 | 29118 | 29118 | Protection Analog Bmk Syst WP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | Brånemark System® |
| 33 | 17332747000082 | 29117 | 29117 | Protection Analog Bmk Syst RP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | Brånemark System® |
| 34 | 17332747000075 | 29116 | 29116 | Protection Analog Bmk Syst NP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | Brånemark System® |
| 35 | 07332747015195 | 35426 | 35426 | Guide Drill | DZI | DRILL, BONE, POWERED | 2 | NA |
| 36 | 07332747178920 | PUR0901 | PUR0901 | NobelSpeedy/Brånemark Syst/Replace Sel TC PureSet™ Plate | KCT | Sterilization wrap containers, trays, cassettes & other accessories | 2 | NA |
| 37 | 07332747178913 | PUR0900 | PUR0900 | NobelSpeedy/Brånemark Syst/Replace Sel TC PureSet™ Tray | KCT | Sterilization wrap containers, trays, cassettes & other accessories | 2 | NA |
| 38 | 07332747177831 | 301202 | 301202 | Lab Screw MUA Omnigrip Mini WP | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 39 | 07332747177824 | 301201 | 301201 | Lab Screw MUA Omnigrip Mini NP/RP | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 40 | 07332747177756 | 300496 | 300496 | Pos Loc Multiple Strmn Std/Plus 6.5 | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 41 | 07332747177749 | 300495 | 300495 | Pos Loc Multiple Strmn Std/Plus 4.8 | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 42 | 07332747177732 | 300494 | 300494 | Pos Loc Multiple Strmn BLvl RC4.1/4.8 | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 43 | 07332747177725 | 300493 | 300493 | Pos Loc Multiple Strmn BLvl NC3.3 | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 44 | 07332747177718 | 29121 | 29121 | Protection Analog NobRpl WP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 45 | 07332747177701 | 29120 | 29120 | Protection Analog NobRpl RP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 46 | 07332747177695 | 29119 | 29119 | Protection Analog NobRpl NP 5/pkg | NDP | Accessories, implant, dental, endosseous | 1 | NobelReplace® |
| 47 | 07332747177350 | 38857 | 38857 | Protection Analog/Drill Guide CC WP 5/pk | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 48 | 07332747177343 | 38856 | 38856 | Protection Analog/Drill Guide CC RP 5/pk | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 49 | 07332747177336 | 38855 | 38855 | Protection Analog/Drill Guide CC NP 5/pk | NDP | Accessories, implant, dental, endosseous | 1 | NA |
| 50 | 07332747177329 | DIB 097-0 | DIB 097-0 | Cover Screw Driver Bmk Syst Hexagon | NDP | Accessories, implant, dental, endosseous | Brånemark System® |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 03770016198004 | 1.X | QyScore | QYNAPSE | ||
| 2 | 03760297030209 | FXSPS001 | Planning software for total shoulder arthroplasty | FX Shoulder Positioning System | PIXEE MEDICAL | |
| 3 | 03760264690115 | 3.2.1 | M'Ath PACS | I M T | ||
| 4 | 03760264690061 | 3.2.1 SR | M'Ath | I M T | ||
| 5 | 03760263520024 | 6.0 | LMS-Liver is an image analysis software application for evaluating CT images cov LMS-Liver is an image analysis software application for evaluating CT images covering the liver area. It is designed to assist radiologists in the evaluation and documentation of lesions. It also provides tools for assessment of lesion evolution over time. LMS-Liver offers measurement tools and 3D registration techniques for characterization and follow-up of the lesions. It also offers reporting capabilities making it possible to generate standardized reports. | LMS-Liver | MEDIAN TECHNOLOGIES | |
| 6 | 03760263520017 | 6.0 | LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qual LMS-Lung/TRACK is intended to provide the radiologists and other clinicians qualified to interpret CT images the ability to:- visualize chest CT datasets acquired in low or normal dose; - mark and automatically/manually measure characteristics (such as diameter, volume) of lung nodules selected by the user;- compare chest CT scans of the same patient over time for quantification of pulmonary lesion evolution (volume growth and doubling time estimation)- generate automatic reports. | LMS-Lung/TRACK | MEDIAN TECHNOLOGIES | |
| 7 | 03760262480015 | 3.1 | EndoSize | THERENVA | ||
| 8 | 03700757200858 | 1.x | spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine spineEOS 1.x allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. | spineEOS | ONEFIT MEDICAL | |
| 9 | 03700757200834 | 3.x | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | hipEOS | ONEFIT MEDICAL | |
| 10 | 03700757200827 | 2.x | / | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | hipEOS | ONEFIT MEDICAL |
| 11 | 03700757200544 | 1.1 | spineEOS allows surgeons to perform preoperative surgical planning of spine surg spineEOS allows surgeons to perform preoperative surgical planning of spine surgeries in case of Adolescent Idiopathic Scoliosis (AIS) or deformative/degenerative spine. The software provides surgical tools for the correction of the curvature, for the placement of cages and for the achievement of osteotomies. | spineEOS | ONEFIT MEDICAL | |
| 12 | 03700757200520 | 2.5 | hipEOS allows surgeons to perform pre-operative surgical planning for hip replac hipEOS allows surgeons to perform pre-operative surgical planning for hip replacement. The program features an extensive regularly updated library of digital 3D models of implants form leading implant manufacturers. It allows the overlay of the 3D/2D implant models on the radiological images and on the 3D reconstruction and permits the selection of appropriate size and position of implant. | hipEOS | ONEFIT MEDICAL | |
| 13 | 03700757200506 | 1.0 | kneeEOS allows surgeons to perform preoperative surgical planning of total kneea kneeEOS allows surgeons to perform preoperative surgical planning of total kneearthroplasties. The software provides surgical tools to analyze preoperative data, to set the resection levels, to position and size the femoral and tibial components and to evaluate the final alignment of the leg. | kneeEOS | ONEFIT MEDICAL | |
| 14 | 03700719700471 | MYRIAN 2.9 | Myrian® is a medical software for processing, management, advanced visualization Myrian® is a medical software for processing, management, advanced visualization, and analysis of multimodality medical images. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including radiologists, surgeons, clinicians and technicians. This device is not indicated for mammography use. | MYRIAN | INTRASENSE | |
| 15 | 03700719700464 | MYRIAN 2.7.6 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 16 | 03700719700457 | MYRIAN 2.8 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 17 | 03700719700440 | MYRIAN 2.7 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 18 | 03700719700433 | MYRIAN 2.6 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 19 | 03700719700426 | MYRIAN 2.5 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 20 | 03700719700419 | MYRIAN 2.4 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 21 | 03700719700402 | MYRIAN 2.3 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 22 | 03700719700396 | MYRIAN 2.2 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 23 | 03700719700013 | MYRIAN 2.1 | Software medical device aimed at reviewing images produced by all standard medic Software medical device aimed at reviewing images produced by all standard medical Imaging devices. It includes DICOM communication, media interchange (printing, CD burning, storing) and reporting features. The software can be run from any standard client platform (such as PC) that might be purchased independently by the end user. Common users are trained medical professionals, including surgeons, radiologist clinicians and technicians. This device is not indicated for mammography use. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA. | MYRIAN | INTRASENSE | |
| 24 | 03665587000095 | 6.1 | MEDWS | MED.E.COM | ||
| 25 | 03665587000088 | 5.6 | MEDWS | MED.E.COM | ||
| 26 | 03665587000071 | 5.4 | MEDWS | MED.E.COM | ||
| 27 | 03665587000064 | 5.2 | MEDWS | MED.E.COM | ||
| 28 | 03665587000057 | 5.0 | MEDWS | MED.E.COM | ||
| 29 | 03665587000033 | 4.18 | MEDWS | MED.E.COM | ||
| 30 | 03665587000026 | 4.17 | MEDWS | MED.E.COM | ||
| 31 | 03665587000019 | 4.14 | MEDWS | MED.E.COM | ||
| 32 | 03665587000002 | 4.15 | MEDWS | MED.E.COM | ||
| 33 | 03665134000714 | KSOF-2602 | PROMAP – 3D PROSTATE SUITE | KOELIS | ||
| 34 | 03665134000684 | KURO-3000-3 | TRINITY | KOELIS | ||
| 35 | 03665134000578 | KURO-4000 | A system based on the PROMAP – 3D Prostate Suite range intended to define prosta A system based on the PROMAP – 3D Prostate Suite range intended to define prostate contour and targets the region of interest on a prostate gland image in anticipation of a fusion with a system compatible with a 3D echography image realized as part of a targeted prostate gland biopsy. | MR DRAW | KOELIS | |
| 36 | 03665134000035 | KURO3000-2 | A mobile workstation composed by a central unit with ultrasound beamformer, a A mobile workstation composed by a central unit with ultrasound beamformer, a tactile screen, a mouse, a touch pen and a footswitch. All these components are assembled on a mobile cart,Optionally a keyboard can be delivered and a trackball mouse can be delivered instead of the mouse. | TRINITY | KOELIS | |
| 37 | 03663999000054 | Software 1.8 | sterEOS workstation software | sterEOS® | EOS IMAGING | |
| 38 | 03663999000047 | Workstation 1.8 | sterEOS workstation | sterEOS® | EOS IMAGING | |
| 39 | 03663999000030 | Software 1.6 | sterEOS workstation software | sterEOS® | EOS IMAGING | |
| 40 | 03663999000023 | Workstation 1.6 | sterEOS workstation | sterEOS® | EOS IMAGING | |
| 41 | 03661489709067 | 0100011575 | e-Ortho Shoulder Software | FOURNITURES HOSPITALIERES INDUSTRIE | ||
| 42 | EKAV101244750 | 11 | 1.012.4475 | Software | DEXIS™ Software | DEXIS LLC |
| 43 | EKAV101135330 | 11 | 10124479 | Software | DEXIS™ Software | DEXIS LLC |
| 44 | EKAV101037680 | 3 | VIXWINPL | Imaging software | Gendex VixWin™ imaging software | GENDEX CORP. |
| 45 | EKAV101034120 | 9 | PLU238 | Enterprise | DEXIS™ Software | DEXIS LLC |
| 46 | EKAV101034110 | 9 | PLU349 | US & International | DEXIS™ Software | DEXIS LLC |
| 47 | EKAV101034090 | 9 | PLU235 | Animal | DEXIS™ Software | DEXIS LLC |
| 48 | EKAV101034080 | 9 | PLU236 | Forensic | DEXIS™ Software | DEXIS LLC |
| 49 | EKAV100879340 | 10 | 1.008.7934 | DEXIS 10 (DEXIS Imaging Suite) | DEXIS LLC | |
| 50 | 00889024486782 | 20-8017-038-00 | 20-8017-038-00 | X-PSI™ | ORTHOSOFT INC |