No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10815411020007 | NL3000 | JAK | System, X-Ray, Tomography, Computed | 2 | CereTom | ||
2 | 10815411020526 | 0-00102-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Huntleigh Enterprise Adapter | ||
3 | 10815411020519 | 0-00187-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Arjo Huntleigh Adapter | ||
4 | 10815411020298 | GMR40 | MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 2 | GMR40 Retrofit Kit | ||
5 | 10815411020281 | 0-00029-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Stryker Zoom Adapter | ||
6 | 10815411020403 | 0-00150-002 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, EXTENDED HILL-ROM PROGRESSA PULMONARY SCAN BOARD | ||
7 | 10815411020397 | 0-00169-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION ASSY, OMNITOM UNIVERSAL TRANSFER BOARD | ||
8 | 10815411020359 | 0-00163-001 | JAK | System, X-Ray, Tomography, Computed | 2 | STRYKER POWERPRO X AMBULANCE SCAN BOARD W/ LATCH LOCK | ||
9 | 10815411020168 | 0-00141-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, STRYKER S3 BED ADAPTER | ||
10 | 10815411020458 | 0-00175-001 | JAK | System, X-Ray, Tomography, Computed | 2 | ADAPTER, HILL-ROM CARE ASSIST ES BED | ||
11 | 10815411020274 | 10-01148-001 | JAK | System, X-Ray, Tomography, Computed | 2 | 30cm Water Phantom | ||
12 | 10815411020267 | 0-NL4000-001 | JAK | System, X-Ray, Tomography, Computed | 2 | CT SCANNER, NL4000 | ||
13 | 10815411020250 | 0-00080-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION PLATE MOUNTED SCANNER | ||
14 | 10815411020106 | 0-00116-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Scanner Drive System | ||
15 | 10815411020687 | 0-NL3000-004 | JAK | System, X-Ray, Tomography, Computed | 2 | CereTom Elite | ||
16 | 10815411020670 | 0-00204-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, STRYKER PROCUITY BED ADAPTER | ||
17 | 10815411020410 | 0-00050-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION HILL ROM ADVANTA BED ADAPTER | ||
18 | 10815411020311 | 0-NL4000-002 | JAK | System, X-Ray, Tomography, Computed | 2 | CT SCANNER, NL4000 ELITE | ||
19 | 10815411020113 | 0-00135-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Universal Scan Board | ||
20 | 10815411020069 | 0-00079-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, PEDIATRIC SCANNING PLATFORM | ||
21 | 10815411020175 | 0-00142-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Hill Rom Bed Adapter | ||
22 | 10815411020663 | 0-NL5000-002 | JAK | System, X-Ray, Tomography, Computed | 2 | OmniTom Elite | ||
23 | 10815411020076 | 0-00084-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Large Veterinary Scanning Platform | ||
24 | 10815411020496 | 0-00181-001 | JAK | System, X-Ray, Tomography, Computed | 2 | HillRom Centrella | ||
25 | 10815411020441 | 0-00174-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, HILL-ROM CHG BED ADAPTER | ||
26 | 10815411020182 | 0-00143-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Hill-Rom Advanta 2 | ||
27 | 10815411020236 | 0-00152-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, STRYKER IN TOUCH LOW BED ADAPTER | ||
28 | 10815411020229 | 0-00132-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, WS CART NL4000 | ||
29 | 10815411020335 | 0-NL5000-001 | JAK | System, X-Ray, Tomography, Computed | 2 | CT SCANNER, NL5000 | ||
30 | 10815411020137 | 0-00138-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION ASSY, HILL ROM PROGRESSA PULMONARY BED ADAPTER | ||
31 | 10815411020120 | 0-00137-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, STRYKER POWER PRO AMBULANCE BED ADAPTER | ||
32 | 10815411020038 | 0-00072-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Neo-Natal Scanning Platform | ||
33 | 10815411020212 | 10-00159-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Mobile ENT Computer Cart, Assembly | ||
34 | 10815411020595 | 0-00192-001 | JAK | System, X-Ray, Tomography, Computed | 2 | MSU STRETCHER | ||
35 | 10815411020588 | 0-00202-002 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, EXTENDED SCANBOARD SHORT POST WITH TARGET | ||
36 | 10815411020342 | 0-NL3000-005 | JAK | System, X-Ray, Tomography, Computed | 2 | CT SCANNER , NL3000 ELITE, RAIL/PLATE CONFIG | ||
37 | 10815411020083 | 0-00086-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Stryker FOB Adapter | ||
38 | 10815411020021 | 0-00036-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Transfer Board Assembly | ||
39 | 10815411020502 | 0-00185-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Stryker Spirit 5700 Adapter | ||
40 | 10815411020472 | 0-00173-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Large Veterinary Platform | ||
41 | 10815411020434 | 0-00171-001 | JAK | System, X-Ray, Tomography, Computed | 2 | PEDIATRIC SCANNING PLATFORM FOR OMNITOM | ||
42 | 10815411020199 | 0-00149-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Stryker Bed Adapter | ||
43 | 10815411020557 | 0-00135-002 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, SILHOUETTE SCANBOARD WITH TARGET | ||
44 | 10815411020380 | 0-00026-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, HILL ROM TRANSTAR STRETCHER ADAPTER 19.5" | ||
45 | 10815411020052 | 0-00027-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Flat Head Scan Board | ||
46 | 10815411020045 | 0-00020-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, OR TABLE ADAPTER | ||
47 | 10815411020014 | 0-00117-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, HILL-ROM TOTALCARE ADAPTER | ||
48 | 10815411020304 | 0-00048-001 | JAK | System, X-Ray, Tomography, Computed | 2 | Hill-Rom Century Adapter | ||
49 | 10815411020571 | 0-00202-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, EXTENDED SCANBOARD LONG POST WITH TARGET | ||
50 | 10815411020373 | 0-00162-001 | JAK | System, X-Ray, Tomography, Computed | 2 | OPTION, STRYKER PRIMEX BED ADAPTER |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B634SW0121940202000 | Version 2.2.1 | Monarch Software Laptop v2.2.1 | Monarch Software Laptop v2.2.1 | AURIS HEALTH, INC. | |
2 | B634SW0121930202000 | Version 2.2.1 | Monarch Software Cart v2.2.1 | Monarch Software Cart v2.2.1 | AURIS HEALTH, INC. | |
3 | B634SW0121920202000 | Version 2.2.1 | Monarch Software Tower v2.2.1 | Monarch Software Tower v2.2.1 | AURIS HEALTH, INC. | |
4 | B634SW0121900201060 | Version 2.1.6 | Monarch Software Laptop v2.1.6 | Monarch Software Laptop v2.1.6 | AURIS HEALTH, INC. | |
5 | B634SW0121890201060 | Version 2.1.6 | Monarch Software Cart v2.1.6 | Monarch Software Cart v2.1.6 | AURIS HEALTH, INC. | |
6 | B634SW0121880201060 | Version 2.1.6 | Monarch Software Tower v2.1.6 | Monarch Software Tower v2.1.6 | AURIS HEALTH, INC. | |
7 | B634SW0032760201050 | Version 2.1.5 | Monarch™ Software Laptop v2.1.5 | Monarch™ Software Laptop v2.1.5 | AURIS HEALTH, INC. | |
8 | B634SW0032760201040 | Version 2.1.4 | Monarch™ Software Laptop v2.1.4 | Monarch™ Software Laptop v2.1.4 | AURIS HEALTH, INC. | |
9 | B634SW0032760201030 | Version 2.1.3 | Monarch™ Software Laptop v2.1.3 | Monarch™ Software Laptop v2.1.3 | AURIS HEALTH, INC. | |
10 | B634SW0032750201050 | Version 2.1.5 | Monarch™ Software Cart v2.1.5 | Monarch™ Software Cart v2.1.5 | AURIS HEALTH, INC. | |
11 | B634SW0032750201040 | Version 2.1.4 | Monarch™ Software Cart v2.1.4 | Monarch™ Software Cart v2.1.4 | AURIS HEALTH, INC. | |
12 | B634SW0032750201030 | Version 2.1.3 | Monarch™ Software Cart v2.1.3 | Monarch™ Software Cart v2.1.3 | AURIS HEALTH, INC. | |
13 | B634SW0032740201050 | Version 2.1.5 | Monarch™ Software Tower v2.1.5 | Monarch™ Software Tower v2.1.5 | AURIS HEALTH, INC. | |
14 | B634SW0032740201040 | Version 2.1.4 | Monarch™ Software Tower v2.1.4 | Monarch™ Software Tower v2.1.4 | AURIS HEALTH, INC. | |
15 | B634SW0032740201030 | Version 2.1.3 | Monarch™ Software Tower v2.1.3 | Monarch™ Software Tower v2.1.3 | AURIS HEALTH, INC. | |
16 | B634SW0032740201020 | Version 2.1.2 | Monarch™ Software Tower v2.1.2 | Monarch™ Software Tower v2.1.2 | AURIS HEALTH, INC. | |
17 | B634MON0007090 | MON-000709 | MON-000709 | Window Field Generator, Connection Cable, Mounting System | Monarch Advanced Imaging Accessory Kit | AURIS HEALTH, INC. |
18 | B634MON0000060 | MON-000006 | The Monarch Bronchoscope enables electro-mechanical articulation and precise con The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.Monarch Bronchscope 2.0/Monarch Platform (P2) | Monarch Bronchscope 2.0/Monarch Platform (P2) | AURIS HEALTH, INC. | |
19 | B634MON000005R0 | MON000005R | MON000005R | The Monarch Platform (Refurbished) enables electro-mechanical articulation and p The Monarch Platform (Refurbished) enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. | Monarch™ Platform (Refurbished) | AURIS HEALTH, INC. |
20 | B634MON00000501R0 | MON-000005-01R | Monarch Endoscopy Platform (P1) System, Refurbished | Monarch Endoscopy Platform (P1) System, Refurbished | AURIS HEALTH, INC. | |
21 | B634MON000005010 | MON-000005-01 | Monarch Endoscopy Platform (P1) Tower Upgrade | Monarch Endoscopy Platform (P1) Tower Upgrade | AURIS HEALTH, INC. | |
22 | B634MON00000501 | MON-000005-01 | Monarch Endoscopy Platform (P1) Tower Upgrade | Monarch Endoscopy Platform (P1) Tower Upgrade | AURIS HEALTH, INC. | |
23 | B634MON0000050 | MON000005 | MON000005 | The Monarch Platform enables electro-mechanical articulation and precise control The Monarch Platform enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator. | Monarch™ Platform | AURIS HEALTH, INC. |
24 | B209CAS2X10 | 2.1 | V3D-Calcium Scoring is a software application used with advanced PC hardware for V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent. | V3D-Calcium Scoring | VIATRONIX INCORPORATED | |
25 | B209CAS2X00 | 2.0 | V3D-Calcium Scoring is a software application used with advanced PC hardware for V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent. | V3D-Calcium Scoring | VIATRONIX INCORPORATED | |
26 | B209CAR1X10 | 1.1 | V3D-Cardiac is a software application used with advanced PC hardware for evaluat V3D-Cardiac is a software application used with advanced PC hardware for evaluating DICOM 3.0 compliant CT images of the human heart. It is designed to aid the physician in analyzing the heart anatomy and detecting anomalies based on contrast enhanced CT images. It provides both coronary artery tracking and left ventricle volume analyzing tools for single or multi-phase CT scan. | V3D-Cardiac | VIATRONIX INCORPORATED | |
27 | B201CGSCENERGY0 | CGSCENERGY | Clear Guide SCENERGY | CLEAR GUIDE MEDICAL, INC. | ||
28 | B201CGOHM0 | CGOHM | CG-OH-M | The device is intended as an accessory hardware to provide input into medical de The device is intended as an accessory hardware to provide input into medical device software by capturing video and other sensory information from the operational field for purposes of future processing. The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. | Clear Guide Optical Head | CLEAR GUIDE MEDICAL, INC. |
29 | B201CGCORE24MR0 | CGCORE24MR | CG-CORE24-MR | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24-MR model is a modified version of CG-CORE24 with significantly reduced ferromagnetic components internally. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
30 | B201CGCORE240 | CGCORE24 | CG-CORE24 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE24 model is a panel PC with a 24" screen. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
31 | B201CGCORE130 | CGCORE13 | CG-CORE-13 | The device is intended as a computer platform to perform computation, display, c The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
32 | 86000594161101 | 9801101000 | 86000594161101 | SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquir SeeFactorCT3 is a cone beam computed tomography x-ray imaging system that acquires sequences of the head includingthe ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibular joint (TMJ),other areas of human skull and neck with sections of upper cervical spine, and upper and lower extremities for use indiagnostic support. The device displays two and three dimensional images for each examined anatomical region.The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals. | SeeFactor CT3 | EPICA MEDICAL INNOVATIONS LLC |
33 | 60889971743572 | OnSight 3D Extremity System | 1743574 | ONSIGHT 3D EXTREMITY SYS W RMT CONSOLE | OnSight 3D Extremity System | CARESTREAM HEALTH, INC. |
34 | 60889971743565 | OnSight 3D Extremity System | 1743566 | ONSIGHT 3D EXTREMITY SYS W ATCH CONSOLE | OnSight 3D Extremity System | CARESTREAM HEALTH, INC. |
35 | 47630039301444 | 017285 | Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector | EmpowerCTA®+ Injector System 1731 ed03 | BRACCO INJENEERING SA | |
36 | 47630039301437 | 017285 | 017285 | Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
37 | 47630039301000 | 017285 | Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA | |
38 | 47630039300904 | 017285 | 017285 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 376300393004711 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300891 | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
39 | 47630039300812 | 017383 | 017383 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 376300393004711 x EDA Module Kit GTIN : 376300393004261 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300822 | EmpowerCTA®+ Injector System with EDA | BRACCO INJENEERING SA |
40 | 47630039300782 | 017285 | 017285 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 376300393004711 x EmpowerSync® Power Supply GTIN : 376300393008391 x Injector GTIN : 37630039300822 | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
41 | 47630039300447 | 017383 | 017383 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1x Remote Control GTIN : 376300393004711 x EDA Module Kit GTIN : 376300393004261 x EmpowerSync® Power Supply GTIN : 376300393004881 x Injector GTIN : 37630039300747 | EmpowerCTA®+ Injector System with EDA | BRACCO INJENEERING SA |
42 | 47630039300430 | 017285 | 017285 | Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 Composed of : 1 x Remote Control (Onyx) GTIN : 37630039300761 // Alternate : 1 x Remote Control GTIN : 376300393004711 x EmpowerSync® Power Supply GTIN : 376300393004881 x Injector GTIN : 37630039300747 | EmpowerCTA®+ Injector System | BRACCO INJENEERING SA |
43 | 37630039301812 | 017418 | 017418 | Injector Mounting Arm, Right | BRACCO INJENEERING SA | |
44 | 37630039301805 | 017417 | 017417 | Injector Mounting Arm, Left | BRACCO INJENEERING SA | |
45 | 37630039301737 | 015781 | EDA Clip | BRACCO INJENEERING SA | ||
46 | 37630039300709 | 017411 | 017411 | Floor Stand Shroud | BRACCO INJENEERING SA | |
47 | 37630039300693 | 017410 | 017410 | Floor Stand | BRACCO INJENEERING SA | |
48 | 37630039300686 | 015781 | 015781 | EDA Clip | BRACCO INJENEERING SA | |
49 | 37630039300679 | 017415 | 017415 | Ceiling Column Short | BRACCO INJENEERING SA | |
50 | 37630039300662 | 017414 | 017414 | Ceiling Column Medium | BRACCO INJENEERING SA |