No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 30817929020092 | IUSP-002 | IUSP-002 | Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ult Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer | ITX,KNF | Transducer, Ultrasonic, Diagnostic,Coagulator-Cutter, Endoscopic, Unipolar (And Transducer, Ultrasonic, Diagnostic,Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | Sonata® Intrauterine Ultrasound Probe | |
2 | 10817929020241 | IUSP-002S | IUSP-002S | Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ult Ultrasound-guided intrauterine electrosurgical diathermy system intrauterine ultrasound transducer, Sterile | ITX,KNF | Transducer, Ultrasonic, Diagnostic,Coagulator-Cutter, Endoscopic, Unipolar (And Transducer, Ultrasonic, Diagnostic,Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | Sonata® Intrauterine Ultrasound Probe |
3 | 10817929020197 | USCON-2200 | USCON-2200 | Ultrasound -guided intrauterine electrosurgical system ultrasound control unit | IYO,KNF | System, Imaging, Pulsed Echo, Ultrasonic,Coagulator-Cutter, Endoscopic, Unipolar System, Imaging, Pulsed Echo, Ultrasonic,Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | Sonata® SMART Tablet |
4 | 10817929020036 | RTN-001 | RTN-001 | ITX | Transducer, Ultrasonic, Diagnostic | 2 | Sonata® Intrauterine Ultrasound Probe Return Kit | |
5 | 10817929020005 | CSKIT-001 | CSKIT-001 | Convenience Kit containing one model RFA-001 sterile single-use ultrasound-guide Convenience Kit containing one model RFA-001 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, and two model DE-001 single-use electrosurgical return electrodes | KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | Sonata® Case Kit |
6 | 10817929020357 | SW-001 | SW-001 | Ultrasound-guided radio-frequency ablation system software | KNF,ITX,IYO | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories),Transducer, Ultrasonic Coagulator-Cutter, Endoscopic, Unipolar (And Accessories),Transducer, Ultrasonic, Diagnostic,System, Imaging, Pulsed Echo, Ultrasonic | 2 | Sonata® System Software |
7 | 10817929020371 | RFA-002 | RFA-002 | Ultrasound-guided intrauterine electrosurgical handpiece/ electrode | KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | Sonata® Radiofrequency Ablation Handpiece |
8 | 10817929020340 | SW-002 | SW-002 | KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | Sonata System Software | |
9 | 10817929020326 | SONATA2-110 | SONATA2-110 | Ultrasound-guided intrauterine electrosurgical system. This system includes a ca Ultrasound-guided intrauterine electrosurgical system. This system includes a cart, ultrasound console, RF generator, and component kit. | ITX,KNF,IYO | Transducer, Ultrasonic, Diagnostic,Coagulator-Cutter, Endoscopic, Unipolar (And Transducer, Ultrasonic, Diagnostic,Coagulator-Cutter, Endoscopic, Unipolar (And Accessories),System, Imaging, Pulsed Echo, Ultrasonic | 2 | Sonata® Sonography-Guided Transcervical Fibroid Ablation System |
10 | 30817929020177 | ACCY-008 | ACCY-008 | Electrical-only medical device connection cable, reusable | KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | Sonata® RFA Handpiece Cable, Reusable |
11 | 10817929020166 | PROKIT-001 | PROKIT-001 | Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guide Convenience Kit containing one model RFA-002 sterile single-use ultrasound-guided intrauterine electrosurgical handpiece / electrode, two model DE-001 single-use electrosurgical return electrodes, and one model ACCY-007 sterile single-use electrosurgical handpiece cable. | KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | Sonata® Procedure Kit |
12 | 10817929020142 | CYL-001 | CYL-001 | General laboratory container, reusable | IYO,ITX,KNF | System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Coag System, Imaging, Pulsed Echo, Ultrasonic,Transducer, Ultrasonic, Diagnostic,Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | Sonata® IUUS Probe Soaking Cylinder |
13 | 10817929020135 | SHPR-001 | SHPR-001 | Sterilization packaging, single use | KNF,ITX | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories),Transducer, Ultrasonic Coagulator-Cutter, Endoscopic, Unipolar (And Accessories),Transducer, Ultrasonic, Diagnostic | 2 | Sonata® IUUS Probe Sterile Shipper Kit |
14 | 10817929020364 | DE-001 | DE-001 | Electrosurgical return electrode, single-use | KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | Sonata® Dispersive Electrode |
15 | 10817929020203 | RFG2-110 | RFG2-110 | Ultrasound-guided intrauterine electrosurgical system generator | IYO,KNF | System, Imaging, Pulsed Echo, Ultrasonic,Coagulator-Cutter, Endoscopic, Unipolar System, Imaging, Pulsed Echo, Ultrasonic,Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | Sonata® System Radiofrequency Generator |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | B616UVXS0 | XS | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
2 | B616UVXR0 | XR | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
3 | B616UVXP0 | XP | General Purpose Diagnostic Medical Ultrasonic Imaging System | UltraVision | ULTRAVISION CORPORATION | |
4 | B510DUS70000 | DUS-7000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
5 | B510DUS5000A1 | DUS-5000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
6 | B510DUS30001 | DUS-3000 | ADVANCED ULTRASOUND | ADVANCED INSTRUMENTATIONS, INC. | ||
7 | B377GMD61VASUS40 | Vascular V4 | GMD61VASUS4 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
8 | B377GMD61ENDUS40 | Endocavity V4 | GMD61ENDUS4 | USB ultrasound probe, general purpose/endocavity. | ClearProbe | GLOBALMEDIA GROUP, LLC |
9 | B377GMD61ABDUS40 | Abdominal V4 | GMD61ABDUS4 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
10 | B377GMD6180NV010 | Neonatal | GMD6180NV01 | USB ultrasound probe, general purpose/neonatal | ClearProbe | GLOBALMEDIA GROUP, LLC |
11 | B377GMD6175VA010 | Vascular | GMD6175VA01 | USB ultrasound probe, general purpose/vascular | ClearProbe | GLOBALMEDIA GROUP, LLC |
12 | B377GMD6175RV010 | Endocavity | GMD6175RV01 | USB ultrasound probe, general purpose/endocavity | ClearProbe | GLOBALMEDIA GROUP, LLC |
13 | B377GMD6150AB010 | Abdominal 5 MHz | GMD6150AB01 | USB ultrasound probe, general use/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
14 | B377GMD6135AB020 | Abdominal 3 MHz | GMD6135AB02 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
15 | B377GMD6135AB010 | Abdominal 3.5-5 MHz | GMD6135AB01 | USB ultrasound probe, general purpose/abdominal | ClearProbe | GLOBALMEDIA GROUP, LLC |
16 | B377GMD6112EY01 | Ophthalmic | GMD6112EY01 | USB ultrasound probe, general purpose/ophthalmic | ClearProbe | GLOBALMEDIA GROUP, LLC |
17 | B3015017750001 | Model 201 | 501775000 | SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ul SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ultrasound imaging Systems facilitating their use as an adjunct to mammography for B-mode ultrasonic screening imaging of the breast when used with a linear array transducer consisting of the following components: Image Acquisition Station Model 201 – PN 501775-000, Image Acquisition Station Software Application V3.1.x, PN 501642, Reading Station Software Application, V3.1.x, PN 501973. | SonoCine Image Acquisition Station | SONOCINE, INC. |
18 | B201CGONE0 | CGONE | Clear Guide ONE | CLEAR GUIDE MEDICAL, INC. | ||
19 | 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. |
20 | B201CGOH0 | CGOH | CG-OH | 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. |
21 | B201CGCORE170 | CGCORE17 | CG-CORE17 | 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-CORE17 model is a panel PC with a 17" screen. | Clear Guide CORE | CLEAR GUIDE MEDICAL, INC. |
22 | B118314170 | Classic | Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series. | Sonocubic 3D Ultrasound Software | MEDGE PLATFORMS INC | |
23 | B118314160 | Classic | Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, an Sonocubic 3D Ultrasound Software is a software intended to acquire, retrieve, analyze and store ultrasound images for computerized three-dimensional image processing, from raw 2D ultrasound series. | Sonocubic 3D Ultrasound Software | MEDGE PLATFORMS INC | |
24 | B017ED102 | EyeSeal Disposable | ED1 | ArcScan Insight 100 | ARCSCAN, INC. | |
25 | B017AS100 | AS100 | AS100-120 | ArcScan Insight 100 | ARCSCAN, INC. | |
26 | B015000010 | 00001 | Accuro | RIVANNA MEDICAL, LLC | ||
27 | 90814277020127 | 21-05012-01 | Sterile Transducer Cover - individual cover in envelope | Sonic Window Sterile Transducer Cover | ANALOGIC CORPORATION | |
28 | 90814277020028 | 10-73868-02 | Replacement unit for Sonic Window Handheld Ultrasound System | Sonic Window Handheld Ultrasound Unit | ANALOGIC CORPORATION | |
29 | 90814277020011 | 10-73869-01 | Docking Station for Sonic Window Handheld Ultrasound System | Sonic Window Docking Station | ANALOGIC CORPORATION | |
30 | 90814277020004 | 10-73690-02 | The Sonic Window is intended for the visualization of vessels and vascular acces The Sonic Window is intended for the visualization of vessels and vascular access guidance of needles and catheters (Insertion of Peripheral Intra Venous (PIV) Catheters, as an example). The Sonic Window is not indicated for use by a layperson and shall be used by prescription only. | Sonic Window Handheld Ultrasound System | ANALOGIC CORPORATION | |
31 | 60889971738837 | Touch Prime Ultrasound System | 1738830 | XE Edition | Touch Prime Ultrasound System | CARESTREAM HEALTH, INC. |
32 | 60889971738820 | Touch Prime Ultrasound System | 1738822 | Touch Prime Ultrasound System | Touch Prime Ultrasound System | CARESTREAM HEALTH, INC. |
33 | 58051887042642 | THD HRStation | 800299 | THD HRStation is an integrated proctological station mainly dedicated to the dia THD HRStation is an integrated proctological station mainly dedicated to the diagnosis of pathologies of the anal canal and specifically to the diagnosis of precancerous lesions.Thanks to the THD Procto Software, it allows the proctologist to have a unique, modular and expandable diagnostic system that, in addition to the realization of high resolution anoscopy, can also allow further diagnostic investigations such as anorectal manometry and Transanal ultrasound. | THD Procto Software System | THD SPA |
34 | 40841716102552 | 017986 | HDi System Overpack p/n 800994-005Contents: System Console, Linear Translation S HDi System Overpack p/n 800994-005Contents: System Console, Linear Translation System (LTS), Patient Interface Module (PIM), Power Supply | ACIST HDi® HD IVUS System | ACIST MEDICAL SYSTEMS, INC. | |
35 | 30856724004357 | 06-050-030 | Clear Image Singles Lite | NEXT MEDICAL PRODUCTS, LLC | ||
36 | 30856724004340 | 17903 | Ultrasound Gel, High Viscosity | ClearWave | NEXT MEDICAL PRODUCTS, LLC | |
37 | 30856724004333 | 17000 | Ultrasound Gel, Medium Viscosity | ClearWave | NEXT MEDICAL PRODUCTS, LLC | |
38 | 30856724004326 | 02-050-030 | Clear Image Singles | NEXT MEDICAL PRODUCTS, LLC | ||
39 | 30856724004203 | 05-812 | Clear Image Ultrasound Gel, Medium Viscosity, 8 oz. | Clear Image | NEXT MEDICAL PRODUCTS, LLC | |
40 | 30856724004197 | 02-812 | Clear Image Ultrasound Gel, High Viscosity, 8 oz. bottle | Clear Image | NEXT MEDICAL PRODUCTS, LLC | |
41 | 30856724004166 | 04-048-020 | Clear Image Sterile Ultrasound Gel, 20ml | Clear Image Singles Sterile | NEXT MEDICAL PRODUCTS, LLC | |
42 | 30856724004159 | 11-405 | LithoClear | NEXT MEDICAL PRODUCTS, LLC | ||
43 | 30856724004142 | 11-601 | LithoClear | NEXT MEDICAL PRODUCTS, LLC | ||
44 | 30856724004135 | 06-400-030 | Clear Image Singles Lite | NEXT MEDICAL PRODUCTS, LLC | ||
45 | 30856724004128 | 06-400B-030 | Clear Image Singles Lite | NEXT MEDICAL PRODUCTS, LLC | ||
46 | 30856724004104 | 02-400-015 | Clear Image Singles, High Viscosity, 15ml | Clear Image Singles | NEXT MEDICAL PRODUCTS, LLC | |
47 | 30856724004098 | 02-400B-015 | Clear Image Singles, High Viscosity, 15ml | Clear Image Singles | NEXT MEDICAL PRODUCTS, LLC | |
48 | 30856724004074 | 02-400-030 | Clear Image Singles, High Viscosity | Clear Image Singles | NEXT MEDICAL PRODUCTS, LLC | |
49 | 30856724004067 | 02-400B-030 | Clear Image Singles, High Viscosity | Clear Image Singles | NEXT MEDICAL PRODUCTS, LLC | |
50 | 30856724004043 | 05-405 | Clear Image Ultrasound Gel, Medium Viscosity, 5L | Clear Image | NEXT MEDICAL PRODUCTS, LLC |