| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00850015699108 | 110044505 | CTE Instruments are stored in an Instrument Tray which has no contact with the p CTE Instruments are stored in an Instrument Tray which has no contact with the patient. Within the tray, the Instruments are held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™ te Modular Bracket, Impaction Sleeve | |
| 2 | 00850015699009 | 43-5399-058-14 | The Canary Medical Drill Bit is used to create the cavity in the patient’s tibia The Canary Medical Drill Bit is used to create the cavity in the patient’s tibial intramedullary canal to fit the CTE implant and cement mantle. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Cemented Tibia Drill Bit | |
| 3 | 00860003118351 | 43-5571-058-14 | The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical Tibial Extension adds 58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Provisional | |
| 4 | 00850015699023 | 43-5399-051-05 | The Canary Medical Tibia Resection Cutting Guide (left or right option) is used The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona® Primary Knee with a Canary Medical Tibial Extension (CTE) Implant. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Tibia Resection Cutting Guide, Left, 5 Deg. | |
| 5 | 00860003118313 | 43-5570-002-14 | The OR Base Station subsystem is intended to send and receive data to and from t The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery. | OUG | Medical Device Data System | 1 | Canary OR Base Station / OR PC App / OR Registration | |
| 6 | 00850015699078 | 43-5907-080-27 | Tibial Cutting guide is placed within a tray, held in place by reusable Modular Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Modular Bracket Tibial Cutting Guide, Left; 5 Deg. | |
| 7 | 00850015699030 | 110043613 | Stem provisional is placed within a tray, held in place by reusable Modular Brac Stem provisional is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Modular Bracket Stem Provisional | |
| 8 | 00850015699054 | 43-5399-052-05 | The Canary Medical Tibia Resection Cutting Guide (left or right option) is used The Canary Medical Tibia Resection Cutting Guide (left or right option) is used for tibia preparation when implanting a Persona® Primary Knee with a Canary Medical Tibial Extension (CTE) Implant. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Tibia Resection Cutting Guide, Right, 5 Deg. | |
| 9 | 00850015699047 | 110043614 | Drill Bit is placed within a tray, held in place by reusable Modular Brackets th Drill Bit is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Modular Bracket Drill Bit | |
| 10 | 00860003118337 | 43-5570-003-14 | Dedicated Laptop PC, part of the OR Base Station System | OUG | Medical Device Data System | 1 | OR Laptop | |
| 11 | 00860003118320 | 43-5570-001-14 | The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient. | OUG | Medical Device Data System | 1 | Canary Home Base Station | |
| 12 | 00860003118306 | 43-5570-058-14 | The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) S The canturio te (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is intended to provide objective kinematic data from the implanted medical device during a patient's total knee arthroplasty (TKA) post-surgical care. The kinematic data are an adjunct to other physiological parameter measurement tools applied or utilized during by the physician during the course of patient monitoring and treatment post-surgery. The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 58mm sized tibial stem extension. The objective kinematic data generated by the CTE with CHIRP System are not intended to support clinical decision-making and have not been shown to provide any clinical benefit. The CTE with CHIRP System is compatible with Zimmer Persona Personalized Knee System. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te | |
| 13 | 00850015699085 | 43-5907-080-29 | Tibial Cutting guide is placed within a tray, held in place by reusable Modular Tibial Cutting guide is placed within a tray, held in place by reusable Modular Brackets that contact the Instruments during sterilization and storage (while inside the Tray), but have no patient contact themselves. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Modular Bracket Tibial Cutting Guide, Right; 5 Deg. | |
| 14 | 00850015699092 | 43-5570-004-14 | The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the s The CTE 14mm x 58mm X-Ray Template is a surgical instrument used to assist the surgeon during preoperative planning. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Canary Tibial Ext 14x58mm X-Ray Template | |
| 15 | 00850015699061 | 43-5399-001-14 | The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument u The Impaction Sleeve is a reusable (provided non-sterile), surgical instrument used to assist in attaching the CTE implant to the Zimmer Biomet Persona® Tibial Baseplate. The Impaction Sleeve protects the implant’s electronic components from impaction forces that occur during assembly. | QPP | Implantable Post-Surgical Kinematic Measurement Knee Device | 2 | canturio™te Impaction Sleeve |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10884521795150 | VDASHSUBEXS01 | Ventilation Dashboard v1.0 Excess Use Subscription | Vital Sync | COVIDIEN LP | |
| 2 | 10884521795143 | VDASHSUB01 | Ventilation Dashboard v1.0 Subscription | Vital Sync | COVIDIEN LP | |
| 3 | 10884521706675 | SBTWR v1.0 | Spontaneous Breathing Trial and Weaning Readiness Application v1.0 | Vital Sync | COVIDIEN LP | |
| 4 | 10884521706668 | EWS v1.0 | Early Warning Score Application v1.0 | Vital Sync | COVIDIEN LP | |
| 5 | 10841522125003 | 96190 | 1.X.X | XPREZZNET,96190 | Xprezznet | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 6 | 10841522123658 | 92848 | 5.x.x | ENTERPRISE NETWORK INTERFACE,92848 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 7 | 10841522123641 | 92843 | 5.x.x | HL7 VITAL SIGNS INTERFACE,92843 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 8 | 10841522123634 | 92842 | 5.x.x | HL7,ADT INTERFACE,92842 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 9 | 10841522123610 | 92880 | 5.x.x | VITAL SIGNS VIEWER,92880 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 10 | 10841522123603 | 92877 | 5.x.x | 12 LEAD ECG INTERFACE,92877 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 11 | 10841522104558 | 94267 | Sentinel | SPACELABS HEALTHCARE (WASHINGTON), INC | ||
| 12 | 10841522104541 | 94267 | XPREZZON and qube Display Options | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | |
| 13 | 10841522100192 | 96190 | 1.3.1 | Spacelabs Network Interface | Xprezznet | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 14 | 10841522100178 | 92880 | V5.2.3 | VITAL SIGNS VIEWER,92880 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 15 | 10841522100161 | 92877 | V5.2.3 | 12 LEAD ECG INTERFACE,92877 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 16 | 10841522100154 | 92876 | V5.2.3 | CUSTOM TRENDS,92876 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 17 | 10841522100147 | 92848 | V5.2.3 | ENTERPRISE NETWORK INTERFACE,92848 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 18 | 10841522100130 | 92843 | V5.2.3 | HL7 VITAL SIGNS INTERFACE,92843 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 19 | 10841522100123 | 92842 | V5.2.3 | HL7,ADT INTERFACE,92842 | Intesys Clinical Suite | SPACELABS HEALTHCARE (WASHINGTON), INC |
| 20 | M58802000780030 | DMS-100 | 020-007800-3 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Cinema MAS & MMS | STEREOTAXIS, INC. |
| 21 | M58800100790010 | Link | 001-007900-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey | STEREOTAXIS, INC. |
| 22 | M58800100784010 | Studio | 001-007840-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey Cinema | STEREOTAXIS, INC. |
| 23 | M58800100781010 | EIF | 001-007810-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey Enterprise Interface | STEREOTAXIS, INC. |
| 24 | 09420012424266 | 900ICON203 | 900ICON203 | F&P InfoUSB | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED |
| 25 | 09352527001192 | VFPROEX24.03 | ProEX Telehealth Hub System FSC2 - NTSC - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 26 | 09352527001185 | VFPROEX23.03 | ProEX Telehealth Hub System GEIS - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 27 | 09352527001161 | VFPROEX21.03 | ProEX Telehealth Hub System Standard - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 28 | 09352527000669 | VFPROEXMOBILE1.01 | ProEX Mobile Telehealth Hub | Visionflex | VISIONFLEX PTY. LTD. | |
| 29 | 09352527000614 | VFPROEX21.03 | ProEX Telehealth Hub System Standard - CLINICIAN v3 | Visionflex | VISIONFLEX PTY. LTD. | |
| 30 | 09352527000607 | VFPROEX26.02 | ProEX Telehealth Hub System FSC3 CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 31 | 09352527000591 | VFPROEX25.02 | ProEX Telehealth Hub System FSC2 CUSTOMER SUPPLIED - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 32 | 09352527000584 | VFPROEX24.02 | ProEX Telehealth Hub System FSC2 - NTSC - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 33 | 09352527000577 | VFPROEX23.02 | ProEX Telehealth Hub System GEIS - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 34 | 09352527000560 | VFPROEX22.02 | ProEX Telehealth Hub System FSC2 PAL - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
| 35 | 09352527000553 | VFPROEX21.02 | The ProEX Imaging Hub is specifically designed and engineered to enable health p The ProEX Imaging Hub is specifically designed and engineered to enable health practitioners all over the world to confidently carry out detailed medical examinations on patients based in regional, remote, rural and urban areas. | Visionflex | VISIONFLEX PTY. LTD. | |
| 36 | 09350855000214 | N05007 | RFID Medical Instrument tag | trophon AcuTrace Medical Instrument Tag | NANOSONICS LIMITED | |
| 37 | 09350855000207 | N05006 | RFID Operator card | trophon AcuTrace Operator Card | NANOSONICS LIMITED | |
| 38 | 08714729975700 | M00420020620 | M00420020620 | LABSYSTEM™ PRO EP Review Workstation Software | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION |
| 39 | 08714729884002 | M00420020300 | LABSYSTEM™ PRO EP Review Workstation Software, V2.7 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | |
| 40 | 08437014572308 | 1006 | KIRO Link is a software intended to store, convert formats, transfer and display KIRO Link is a software intended to store, convert formats, transfer and display the medical data required for the integration and workflow management functionalities of compounding associated technologies. These technologies include customer site software (Computerized Physician Order Entry (CPOE), logistics, quality control, etc.), Pharmacy Compounding Devices (PCDs) and compounding assisting software. The software is intended to be used only by qualified pharmacy personnel. | KIRO Link | KIRO GRIFOLS SL. | |
| 41 | 08052286590173 | EI KT0 0005 521 | Echolaser Smart Interface (ESI) and its accessories | Echolaser Smart Interface (ESI) | ELESTA SPA | |
| 42 | 08033737713037 | THD Procto Software | 760004 | The THD Procto Software System is a diagnostic system intended to be used to inv The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for:- Endoanal ultrasound (trans-rectal ultrasound / echography)- Anoscopy exams- Manometry exams | THD Procto Software System | THD SPA |
| 43 | 07613327505245 | 0101-2200 | 0101-2200 | Digital Port Connector | ADAPT | STRYKER LEIBINGER GMBH & CO. KG |
| 44 | 07613327482690 | 9222110000 | 9222-110-000 | System 9 Non-Sterile Battery, Small | N/A | STRYKER CORPORATION |
| 45 | 07613327482652 | 9126110000 | 9126-110-000 | System 9 Non-Sterile Battery, Large | N/A | STRYKER CORPORATION |
| 46 | 07613327467888 | 4608000000 | 4608-000-000 | System 9 Sagittal Saw | Sabo | STRYKER CORPORATION |
| 47 | 07613327467871 | 4605000000 | 4605-000-000 | System 9 Cordless Driver Handpiece | NA | STRYKER CORPORATION |
| 48 | 07613327467864 | 9209000000 | 9209-000-000 | System 9 Stryker Saw | Precision | STRYKER CORPORATION |
| 49 | 07613327467857 | 9208000000 | 9208-000-000 | System 9 Sagittal Saw | NA | STRYKER CORPORATION |
| 50 | 07613327467840 | 9207000000 | 9207-000-000 | System 9 Sternum Saw | NA | STRYKER CORPORATION |